The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:
- Develop and commercialize devices using structured prouct development process.
- Provide guidance and input regarding product development.
- Regularly interface with staff and leaders in Contract Manufacturing, Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs.
- Regularly interact with external development partners and components suppliers.
- Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.
- Write and execute Design Verification protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods.
Quality Systems Compliance:
- Understand, implement and maintain Pharma Quality Policy and Pharma Quality System (PQS) in the department.
- Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.
- Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
- Create and review discrepancy, change and risk management documents for Devices Teams, as appropriate.
- Ensure compliance of training to PQS and job-related requirements.
- Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
- Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
- Participate in hazards analyses and design assessments and reviews.
- Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
- Education and Industry Experience:
- B.S, M.S, Ph.D or advanced degree in Engineering, with preferences for Mechanical Engineering or equivalent.
- At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
- Experience in the Pharmaceutical, Biotech or Medical Device industry is expected, with previous work on DOE, problem solving and modelling using physical rules.
Strong skills in relevant modeling, design controls and/or statistical analysis.
- Engineering: Electromechanical system design, System engineering, Process/Industrial Engineering, Injection molding.
- Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
- Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatability, Design for Manufacturability, Molding.
- Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
- Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
- Six Sigma (Green/Black Belt): DMAIC and DFSS.
- Human Factors Evaluations: User needs research, Usability engineering and associated risk analyses.