Principal Scientist, Combination Products - Inhalation Devices
Merck
9 hours ago
Remote friendly (Rahway, NJ)
United States
Clinical Research and Development
Responsibilities:
- Lead and implement medical device and combination product design controls for new and inline products, from early design concept through commercialization to support regulatory filing, product launch, and post-market surveillance.
- Lead/contribute to device development and design controls for assigned projects.
- Lead implementation and/or ensure effective execution of the device development strategy and design controls, aligned with management-approved plans and corporate policies; communicate clearly with cross-functional stakeholders and external suppliers.
- Proactively resolve project obstacles; communicate strategy and design controls approach within Device Development and with external suppliers.
- Understand and apply regulatory/compliance requirements related to design controls and risk management.
- Lead preparation of materials for program presentations for management review and regulatory submission.
- Develop, implement, and continuously improve design controls processes, procedures, and tools.
- Stay current with relevant regulations, technologies, and standards; share knowledge with others.
Qualifications:
Minimum Requirements:
- B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other engineering + 15 years related experience.
- Broad knowledge of medical device development, design controls, and risk management.
- Led and managed development of DHF (design history file) deliverables.
- Subject matter expert in at least one medical device development or design controls area.
- Knowledge of U.S. and global medical device/healthcare regulations (including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.).
- Proven analytical skills in product design, development, and evaluation.
- Self-motivated; able to work independently.
- Proven ability to work with teams of diverse skill sets/backgrounds.
- Strong interpersonal skills and strategic thinker; influence without formal authority; present ideas to senior leadership.
- Excellent communication, presentation, negotiation, project management, and organizational skills.
- Ability to quickly learn advanced domain knowledge.
- Ability to multitask continuously.
Preferred Requirements:
- Master’s degree (same disciplines) + 12 years related experience.
- Experience with drug-device combination products or medical device components of combination products.
- Enterprise-level development project leadership experience.
- Experience with device design, requirement management, FMEA, design verification/validation, statistical sampling, and control strategy.
- Experience with regulatory filings.
- Working knowledge of ISO 11608 and ISO 11040.
Required Skills:
- Combination products, design controls, development projects, Dry Powder Inhalers (DPI), inhalers, medical device quality systems, medical device design, risk management, stakeholder communications.
Application Instructions:
- Apply through https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee). Apply by the deadline stated on the posting.
- Lead and implement medical device and combination product design controls for new and inline products, from early design concept through commercialization to support regulatory filing, product launch, and post-market surveillance.
- Lead/contribute to device development and design controls for assigned projects.
- Lead implementation and/or ensure effective execution of the device development strategy and design controls, aligned with management-approved plans and corporate policies; communicate clearly with cross-functional stakeholders and external suppliers.
- Proactively resolve project obstacles; communicate strategy and design controls approach within Device Development and with external suppliers.
- Understand and apply regulatory/compliance requirements related to design controls and risk management.
- Lead preparation of materials for program presentations for management review and regulatory submission.
- Develop, implement, and continuously improve design controls processes, procedures, and tools.
- Stay current with relevant regulations, technologies, and standards; share knowledge with others.
Qualifications:
Minimum Requirements:
- B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other engineering + 15 years related experience.
- Broad knowledge of medical device development, design controls, and risk management.
- Led and managed development of DHF (design history file) deliverables.
- Subject matter expert in at least one medical device development or design controls area.
- Knowledge of U.S. and global medical device/healthcare regulations (including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.).
- Proven analytical skills in product design, development, and evaluation.
- Self-motivated; able to work independently.
- Proven ability to work with teams of diverse skill sets/backgrounds.
- Strong interpersonal skills and strategic thinker; influence without formal authority; present ideas to senior leadership.
- Excellent communication, presentation, negotiation, project management, and organizational skills.
- Ability to quickly learn advanced domain knowledge.
- Ability to multitask continuously.
Preferred Requirements:
- Master’s degree (same disciplines) + 12 years related experience.
- Experience with drug-device combination products or medical device components of combination products.
- Enterprise-level development project leadership experience.
- Experience with device design, requirement management, FMEA, design verification/validation, statistical sampling, and control strategy.
- Experience with regulatory filings.
- Working knowledge of ISO 11608 and ISO 11040.
Required Skills:
- Combination products, design controls, development projects, Dry Powder Inhalers (DPI), inhalers, medical device quality systems, medical device design, risk management, stakeholder communications.
Application Instructions:
- Apply through https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee). Apply by the deadline stated on the posting.