Manager, Combination Product Development

$111,000 - $156,133/Yr

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 Incorporated 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 individual in this role will be responsible for generating process, product, and life cycle-related metrics through statistical analysis, which is essential for informed decision-making throughout the product development process. In addition to metrics generation, the Manager will conduct risk assessments and maintain a risk management file, including an annual review of the User Failure Mode and Effects Analysis (UFMEA). The role also involves generating a design history file for new products and coordinating characterization studies, which are vital for understanding product performance and safety. The Manager will work closely with cross-functional teams to develop user requirements and design inputs, ensuring that all aspects of the product development align with regulatory expectations and user needs. Another key responsibility is leading complaint investigations related to combination products and/or devices, acting as the primary point of contact for the device manufacturer. This includes organizing regular technical meetings to facilitate communication and collaboration. The Manager will also draft Investigational New Drug (IND) submissions for the combination product and perform technical assessments of device changes, owning the change control process. Scheduling and coordinating design reviews, project planning for combination product development activities, and performing technical reviews of labeling, Instructions for Use (IFU), and training material changes are also part of the role. The Manager will represent the team in Chemistry, Manufacturing, and Controls (CMC) meetings, assessing the impact of device and combination products on overall project goals. This position requires a proactive approach to working with cross-functional team members to ensure successful product development and compliance with industry standards.

Responsibilities

• Generate process, product, and life cycle related metrics through statistical analysis
• Conduct risk assessment/analysis 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 team to develop user requirements and design inputs
• Lead complaint investigations involving combination product and/or device
• Act as point of contact for the Device manufacturer and organize regular technical meetings
• Draft IND submissions for the combination product
• Perform device changes technical assessment and own the change control process
• Schedule and coordinate design reviews
• Project planning for the combination product development activities
• Perform technical review of any labeling, IFU and training material changes
• Represent in CMC meeting responsible to assess device and combination product impact
• Work effectively with cross functional team members

Requirements

• Minimum 5 years of Engineering/Operations/new product development experience
• Bachelor's degree in engineering or science
• Design Control and Risk Management 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

• Certified Quality Engineer or similar preferred
• Combination product development experience preferred
• Statistical expertise preferred (Minitab or other statistical tools experience)
• CAPA lifecycle experience, including root cause investigation including Root cause analysis (RCA) techniques required
• Change Control experience required

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 on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer