Manager, Combination Product Development

Insmed Incorporated - Bridgewater Township, NJ

Full-time - Mid Level

Bridgewater Township, NJ

Professional, Scientific, and Technical Services

About the position

The Manager, Combination Product Development at Insmed plays a crucial role in supporting the design and development activities for new combination products. This position is integral to ensuring that the products meet the necessary regulatory and quality standards while also addressing the needs of patients with serious and rare diseases. The manager will be responsible for generating process, product, and life cycle-related metrics through statistical analysis, which is essential for informed decision-making and continuous improvement in product development. In addition to metrics generation, the role involves conducting risk assessments and maintaining a comprehensive risk management file, including an annual review of the User Failure Mode Effects Analysis (UFMEA). The manager will also be tasked with creating and maintaining the design history file for new products, which is a critical component of the product development lifecycle. Coordination of characterization studies and collaboration with cross-functional teams to develop user requirements and design inputs are also key responsibilities. The manager will lead complaint investigations related to combination products and serve as the primary point of contact for the device manufacturer, organizing regular technical meetings to ensure alignment and address any issues that arise. Drafting Investigational New Drug (IND) submissions for the combination product and performing technical assessments for device changes are also part of the role. The manager will oversee the change control process and schedule design reviews to ensure that all aspects of the product development are thoroughly evaluated. Additionally, the manager will represent the team in Chemistry, Manufacturing, and Controls (CMC) meetings, assessing the impact of device and combination product changes. This position requires a proactive approach to project planning for combination product development activities and effective collaboration with cross-functional team members to achieve project goals.

Responsibilities

• Generate process, product, and life cycle related metrics through statistical analysis
• Conduct risk assessment and maintain a risk management file including annual review of UFMEA
• Generate design history file for new products
• Coordinate characterization studies and study design
• Work with cross-functional teams to develop user requirements and design inputs
• Lead complaint investigations involving combination products and/or devices
• Act as the point of contact for the device manufacturer, organizing regular technical meetings
• Draft IND submissions for the combination product
• Perform technical assessments for device changes and manage the change control process
• Schedule and coordinate design reviews
• Perform technical review of any labeling, IFU, and training material changes
• Represent the team in CMC meetings to assess device and combination product impact
• Collaborate effectively with cross-functional team members

Requirements

• Minimum 5 years of Engineering/Operations/new product development experience
• Bachelor's degree in engineering or science
• Certified Quality Engineer or similar preferred
• Design Control and Risk Management experience required
• Combination product development experience preferred
• Statistical expertise preferred (Minitab or other statistical tools experience)
• CAPA lifecycle experience, including root cause investigation and RCA techniques required
• Change Control experience required
• Working knowledge of FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, ISO 14971:2007, EU Medical Device Regulation is required
• Excellent communication skills (verbal and written)
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook)

Nice-to-haves

• Experience with statistical tools such as Minitab
• Familiarity with CAPA lifecycle processes
• Knowledge of FDA and ISO regulations related to medical devices

Benefits

• Flexible approach to where and how we work
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break
• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health online digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer