Careers
Full Time
Design Quality Engineer
Provide Quality Engineering support to ensure the successful development and continual improvement of products. Support the Quality Management System (QMS) while working with design and manufacturing teams. This individual will be expected to apply his/her knowledge of Design Control principles and quality engineering techniques to positively collaborate in product development efforts. Use quality engineering concepts including, but not limited to, design control, process control, risk management, supplier quality, root cause analysis, and continuous improvement activities. Ensure desired design and product performance requirements are met in compliance with applicable regulatory, customer, and client requirements. Working knowledge of medical device regulations (FDA 21CFR820, ISO13485, ISO14971).
Position Duties & Responsibilities
- Responsible for ensuring product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.
- Participate on cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA, PFMEA, and Risk Management Report).
- Participate on cross-functional teams for the review and disposition of nonconforming product or components.
- Prepare and review documentation with a high degree of accuracy, completeness, and effectiveness
- Participate in the development of Design Verification and Validation test plans / protocols and provide guidance on Product Requirements compliance.
- Participate in Design Reviews.
- Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.
- Knowledge of Design History File requirements according to ISO 13485:2016 and FDA 21 CFR 820
- Provide guidance to engineers and other design and development stakeholders regarding requirements for Design Input and Output, Design Verification and Validation, Risk Management, and Test Method Validation
- Reviews master test plans that encompass Design Verification and Validation and Test Method Validation activities
- Promotes a continuous improvement culture in Design Control activities and proactively utilizes quality tools with design team
- Maintains knowledge of current regulatory requirements and standards as they pertain to the development and release of product, particularly medical devices
Education & Experience Requirements:
- Bachelor’s degree (B.S.) in an Engineering, Technical, or Scientific field
- Minimum of 6 years of relevant experience, or advanced degree with minimum of 4 years relevant experience
- Working knowledge of development for medical devices (Design Control Process)
- Working knowledge of quality systems and quality assurance processes and principles with a focus on product development and verification and validation activities and risk management activities (ISO 14971)
- Good knowledge of risk management processes (system risk analysis, DFMEA)
- Prior experience working in medical device industry and with product submissions to regulated bodies (e.g., FDA) preferred
- CQE or Green Belt certification preferred
- Experience with statistical techniques (e.g., DOE, ANOVA) preferred
- Excellent written and oral communication skills preferred
- Strong organizational, problem-solving, and analytical skills
Full Time
Validation Engineer
Validation Engineer will be responsible for supporting the Validation of various equipment/systems and processes for new and existing pharmaceutical and medical device clients.
Position Duties & Responsibilities
- Gain exposure and apply your expertise to the commissioning, qualification, and validation of key bench top and some process equipment ensuring top quality standards are being met.
- Authoring and executing Validation Lifecycle documents such as Validation Master Plan (VMP), Validation Plan (VP), User Requirements Specifications (URS), Risk Assessments, Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols/report in accordance with corporate and departmental procedures.
- Leverage and develop your problems solving abilities as you support the assessment of deviations, investigation, and change controls for validation activities in a regulatory setting.
- Apply and expand your knowledge of cGxP regulations as you author and execute validation studies.
- Perform Validation Periodic Review for various systems including process equipment, computerized systems, and laboratory equipment. Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across sites to determine status, gaps, and corrective actions.
- Perform equipment risk assessments to assess impact of system functionality and control on product quality.
- Represent Validation and participate on cross-functional teams to assist with deviations investigation, CAPA, and change controls write-up.
- Draft, revise, and provide technical input with respect to Standard Operating Procedures development.
- Ensure that projects are implemented in accordance with the agreed scope and timelines.
Education & Experience Requirements:
- BS or MS in Engineering field is required, or equivalent experience.
- Minimum 2 years of hands-on experience preparing and executing Validation lifecycle documents (at least IQ/OQ/PQ) for related facilities, utilities, and process equipment in Life Science (medical device, biopharmaceutical, pharmaceutical, etc.).
- Familiarity with current industry standards cGMP, GLP, GAMP5, and CFR21 Part 11.
- Strong ability to work in a team environment and capability to engage and energize others to reach their fullest potential and performance.
- Excellent communication skills – verbal, written, listening, and interpersonal with the ability to transfer knowledge to others.
- Ability to demonstrate a sense of urgency, flexibility, and accountability.
Full Time
Post Market Surveillance Specialist – Remote
The Post Market Surveillance Specialist is to support the reporting process, assuring compliance with national and international regulations. Monitor the performance of a medical device after release to the market. Ensure Post Market Surveillance plans and reports are consistent with applicable regulations, standards, and established procedures.
Position Duties & Responsibilities
- Responsible for leading, planning, creating and maintaining the post market surveillance system including optimization of the standard operating procedures and work instructions.
- Develop and execute a Post Market Surveillance Master Schedule to support EU to maintain business continuity and efficiency post EUMDR implementation of BVI
- Responsible for leading, creating and maintaining post market surveillance documents including post market surveillance plans and reports (Post Market Surveillance Report / Periodic Safety Update Reports) according to regulations (EU) 2017/745, MDD guideline 92/42 / EEC (, ISO 13485 and FDA.
- Collaborate with functional teams to collect, review, and analyze data for the Post Market Surveillance (PMS) process
- Schedule and facilitate Post Market Surveillance meetings to discuss plans and reports
- Collect, review, and edit Post Market Surveillance data for Clinical Evaluation Reports
- Responsible for actively monitoring and trending product performance (collection, evaluation and analysis of internal and external data sources like complaint data, adverse events, CAPAs, recalls, comparator and market data, feedback, etc.)
- Generate plans and reports to ensure compliance with evolving regulations
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
Education & Experience Requirements:
- Bachelor’s degree required or experience of such kind and amount as to provide a comparable background
- Minimum 4-year experience in the field of medical device industry preferred
- Must be proficient with Microsoft Word, Excel and PowerPoint
Full Time
Clinical Scientist
The Clinical Scientist is an experienced professional who will work in collaboration with clinical operations, regulatory, quality assurance, and compliance. The incumbent will develop and review clinical evidence and post-market surveillance data for interim / study reports to applicable regulatory bodies, conferences, and internal reporting to senior management.
Position Duties & Responsibilities
- Author documentation for US/OUS regulatory submissions, such as the Annual Progress Reports (APR), Clinical Evaluation Reports (CER), Post Market Clinical Follow-up (PMCF), and Clinical Study Reports
- Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market clinical evidence generation strategies that consider evidence needs for EU Medical Device Regulations (EU MDR).
- Facilitate clinical evidence reviews with cross functional team to align on clinical evidence strategies, document / track decisions and risks, and write PMCF Plans.
- Write high quality Post-market Clinical Follow-up (PMCF) plans and Post-market Clinical Follow-up (PMCF) reports.
- Provide subject matter expertise on clinical safety, efficacy, marketability, and utility on data provided from clinical trials
- Assist in the development study protocols, case report forms (CRFs), informed consent forms (ICFs), and other applicable study documentation used in current and new study protocols
- Work with the data management team to understand the analysis and literature, and draft solid narratives for a diverse audience of scientists, clinicians, and regulatory bodies
Education & Experience Requirements:
- Master’s degree or higher
- 3 to 5 years of experience in a clinical environment or medical device industry
- Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans / reports strongly preferred.
- Previous experience developing strategies to generate clinical evidence is strongly preferred.
- Experience authoring new study protocols, CRFs, ICFs, Reports, and other applicable study materials for clinical trial use
- Ability to review scientific literature and data reports to form summary narratives
Full Time
CER Writer/ Medical Writer
As a CER Writer must have experience within the medical device industry and will have a highly methodical clinical evaluation approach to develop benefit/risk profiles, knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation to be considered.
Position Duties & Responsibilities
- Develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.
- Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes development of literature search strategies and methodical evaluation of medical literature.
- Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategies to address gaps.
- Ensure alignment of clinical data with risk documentation, and to contribute to product labeling.
- Aid in the development of regulatory responses for regulatory submissions
- Responsible for the writing of Clinical Evaluation Plans
- Responsible for compliant writing of Clinical Evaluation Reports within this business in accordance to local procedures, the client’s guidelines and regulatory requirements
- Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, the client’s guidelines and regulatory requirements
Education & Experience Requirements:
- BA, BS, or BSN is required; advanced degree ((PhD, research-based MS, MD, RN/DVM) is preferred
- A minimum of 3 years of related job experience is required for this position
- Analytical skills, including strong familiarity with scientific literature
- Strong medical/scientific writing skills
- Familiarity with MEDDEV 2.7/1 Rev 4 and EU MDR
- Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation is required
Full Time
Sr. Regulatory Affairs Specialist - Remote
The Specialist will ensure that the client’s products and procedures comply with regulatory requirements. Oversees/Manages the regulation process for products requiring regulatory agency licensing, registration or clearance, including filing necessary applications/submissions. Coordinates the accumulation of technical information and creates submissions for medical devices for approval, license, registration or clearance in any region.
Position Duties & Responsibilities
- Supporting the development of strategies for regulatory approval of company products
- Manage and coordinate submission activities for a variety of device regulatory approvals including: 510(k) and premarket approvals, international design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings
- Responsible for performing CMC activities for assigned products for US, EU MDR/IVDR, Health Canada and rest of the world (ROW).
- Responsible for development of product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets.
- Responsible for the interactions with the FDA, the EU Notified Body, and Health Canada.
- Participate in change control meetings. Review and approve requests. Notify Regulatory Bodies of changes that impact clearances, licenses, etc.
- Perform labeling reviews/approvals as required.
- Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions.
- Create 510(k) submissions for Domestic Market (FDA). Submit Q-Submission Meetings, such as pre-submission and issue meetings, to the FDA as needed.
- Create Technical Files, Design Dossiers and Health Canada notifications of product changes for submission to the designated Regulatory Agency to obtain/maintain CE Marking.
- Review and Maintain (MDD) Technical Files and Design Dossier/(MDR/IVDR) Technical Documentation after receiving CE Marking.
- Coordinate with applicable stakeholders, to support submissions and testing requirements.
- Attend and/or lead Regulatory meetings.
Education & Experience Requirements:
- Bachelor’s degree (B. A./B.S.) from four-year college or university;
- At least 3 years of work experience in Regulatory Affairs in medical industry
- Understanding of 510(k) filing, device listing and registration, and labeling regulations
- Knowledge of European Medical Device regulations, EU MDR reporting and ISO 13485
- Experience with FDA audits, device registrations and listing requirements and device recall regulations
- Certificates, Licenses, Registrations: RAC certification is preferred.
- Other Skills and Abilities: Knowledge and understanding of US, EU MDR and international medical device regulations.
Experience:
- Regulatory: 5 years (Required)
- 510(k): 2 years (Required)
- FDA, EU: 4 years (Required)
Full Time
Manufacturing Engineer
The Manufacturing Engineer plans, directs, and coordinates manufacturing processes for medical device products, and supports Operations in a way to assure a quality product is produced in a timely manner. Provide engineering and technical services to the Value Stream to achieve the overall manufacturing goal of consistently producing quality, low cost products which meet or exceed customer expectations by addressing major production problems, ensuring optimum manufacturing methods and techniques and implementing cost improvement programs.
Position Duties & Responsibilities
- Ensures that manufacturing processes and procedures comply with FDA, OSHA, ISO, corporate and divisional regulations, policies, and procedures (i.e., process qualification/validation, operation procedures, accurate standards, documentation, etc.).
- Identifies and resolves repetitive and major production issues that are affecting department performance especially when resolutions of such issues require technical solutions.
- Supports new product programs by partnering with Product Development and Value Stream Team, acting as liaison and transfer engineer, for new product introduction into manufacturing in the most cost effective, timely and efficient manner.
- Work with Product Development Engineers to develop processes for new products.
- Work with Operations, Accounting, and Global Product Managers to increase profit margins of current products which do not meet company requirements.
- Assure projects follow design controls established by QSPs (Quality System Procedures).
- Provide support to the calibration department in writing/performing calibration procedures.
- Work with Quality Assurance and Product Development to verify/validate critical processes or products.
Education & Experience Requirements:
- Bachelor’s Degree in Engineering
- A degree in Mechanical, Electrical, Production, or Manufacturing Engineering preferred
- A minimum of 2 years’ experience in manufacturing environment is required
- A proven track record of cost reduction and work simplification is preferred.
- Six Sigma Green Belt desired & Solid understanding of Lean Principles preferred.
- Familiarity with programs such as Excel, AutoCad, MiniTab, Microsoft Word, Power Point, etc.
- Thorough understanding of medical device manufacturing, especially as it relates to FDA ( GMP ) manufacturing requirements.
Full Time
Computer System Validation (CSV) Engineer
CSV Engineer will work across teams, including Operations and Quality, to help ensure that direct impact computerized systems are qualified and maintained in a qualified state. The engineer will also lead the effort to commission no impact computerized systems as needed.
Position Duties & Responsibilities
- Participate in development of User Requirements, Installation, Operational, and Performance Qualification Protocols
- Execute IQ/OQ/PQ protocols
- Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
- Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
- Perform testing of the entire SDLC, including version/change control and new software rollouts.
- Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.
- Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
- Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).
Education & Experience Requirements:
- BS in Engineering, Science or equivalent technical degree.
- 5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.)
- Excellent written and verbal communication skills; excellent technical writing skills.
- Ability to work effectively in a fast-paced multitasking environment.
- Computer System Validation experience within the medical device, laboratory, or pharmaceutical industries.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
Full Time
Senior Packaging Engineer
The Senior Packaging Engineer will be responsible for the designing, developing, and validating a wide variety of package designs to support the development of devices that are of a complex nature. He or she will work in a matrix/cross functional product development environment and be primarily responsible for the project leader’s role to bring a package design from concept through commercialization. A thorough understanding of ISO13485, ISO11607 and Process Validation is General responsibilities include packaging/manufacturing process evaluation, troubleshooting and support of in-house packaging/labeling/sealing equipment of products and processes.
Position Duties & Responsibilities
- Leads the design of new packages and manufacturing processes
- Directs the generation of prototype samples to evaluate new materials and/or design concepts.
- Leads the Risk Analysis role for the package design and process FMEA’s.
- Advanced knowledge of ISO13485 (Design Controls) and ISO11607 (Packaging Validation).
- Complete knowledge of packaging and regulatory standards that drive the medical device industry.
- Ability to analyze and develop new testing criteria and requirements.
- Identify customer requirements for a new package designs.
- Contribute to continuous improvements in overall product cost and quality.
- Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration.
- Maintain documentation associated with packaging/manufacturing processes.
- Provide technical support for production packaging/labeling tools and software including assembly/sealing equipment and automation.
- Partner with Manufacturing to develop lean principals to implement solutions for product packaging, labeling and sealing/assembly.
- Create standardized work and process maps that result in an optimized production system and extended value stream.
- Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities. (IQ, OQ, PQ)
- Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR’s and CAPA.
- Application of statistical and analytical methods such as SPC, SQC and DOE.
Education & Experience Requirements:
B.S. in Packaging Engineering required M.S. /MBA preferred plus 5+ years of experience required.
Full Time
Sr. Full Stack Developer
Senior Full Stack Developer with 5+ years’ experience in the full software development life cycle, including coding standards, code reviews, source control management, build processes, testing, peer review, and operations.
Position Duties & Responsibilities
- Participate in all phases of Agile methodology (planning, grooming, coding sprint items)
- Gain knowledge and control of our loyalty platform integration points (live API’s, Batch, Queue based processing).
- Participate in design sessions; work with product owners and team members to solve acceptance criteria
- Build and maintain all configuration and business logic rule documentation
- Assist other team members through coaching and mentoring
- Promote and demonstrate good coding practice and patterns for the team
- Set accurate time estimates and scope of work for tasks and/or projects assigned to you
- Fill information gaps as needed to accomplish gaps
- Develop simple solutions to complex problems
- Suggest innovative new ways to improve processes and/or components of work
- Effectively work with other groups and third parties
Education & Experience Requirements:
- 5+ years of experience designing and developing applications and components using Java and Spring
- 5+ years of experience in front-end web application development
- 2+ years of experience designing and developing applications using Angular (Prefer version 7+)
- 3+ years of experience developing RESTful services using JSON
- Experience developing microservice cloud applications (Oracle, AWS, or Azure)
- 3+ years of experience developing SQL multi-table queries, inserts, and updates (Prefer Oracle / PostgreSQL)
- Experience tuning SQL statements with execution explain plans
- Familiarity with Agile (e.g., Scrum Process)
Full Time
Big Data Engineer
Position Duties & Responsibilities
- Develop a scalable and resilient cloud data platform and scalable data.
- Develop, operate and drive scalable and resilient data platform to address the business requirements, drive technology and business transformation.
- Ensure industry best practices around data pipelines, metadata management, data quality, data governance and data privacy; design and implement business-specific data pipelines.
- Be a thought leader and partner in the development and execution of the Enterprise Technology Strategy.
- Assist with the Leadership and collaboration with engineering organizations within Change to manage and optimize the portfolio.
- Ensure industry best practices around data pipelines, metadata management, data quality, data governance and data privacy.
- Build highly scalable AWS Infrastructure (from scratch or through 3rd party products) to enable Big Data Processing in the platform.
Education & Experience Requirements:
- At least 4 years working experience in big data technologies
- Experience with Big Data tech stack, including Hadoop, Java, Spark, Scala, and Hive, NoSQL data stores
- Experience leading design and development of large systems and worked with large engineering teams
- Experience with public Clouds, including AWS
- 3+ years of experience with Big Data pipelines with Spark in Java, Scala, Python
- 3+ Years of extensive AWS experience in building Enterprise scale applications and services
- 3+ Years of experience with AWS services
- S or MS in Computer Science or Engineering