Manager, Combination Product Development - Insmed Incorporated

Company Description:

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions:

 

	Consistently Ranked Science’s Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we’ve been named the No. 1 company to work for in the biopharma industry in Science’s Top Employers survey for four years in a row.

 

A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.

 

Overview:The primary function of this Manager, Combination Product Development is to support design and development activities for new combination products.Responsibilities:

• Generate process, product, and life cycle related metrics through statistical analysis
• Risk assessment/Analysis/ Risk management file including annual review of UFMEA
• Generate design history file for new products
• Study design and coordination of characterization studies
• Work with cross functional team to develop user requirements and design inputs
• Lead complaint investigations involving combination product and/or device
• Point of contact for the Device manufacturer including organizing regular technical meetings with Device Manufacturer
• Draft IND submissions for the combination product
• Perform device changes technical assessment and own the change control process for the change
• Schedule and coordinate the design reviews
• Project planning for the combination product development activities
• Perform technical Review of any labeling, IFU and training material changes.
• Representative in CMC meeting responsible to assess device and combination product impact
• Work with cross functional team members effectively

Education and Experience:

• Minimum 5 years of Engineering/Operations/new product development experience
• Bachelor’s degree in engineering or science
• Certified Quality Engineer or similar preferred

Required/Preferred Skills:

• 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 including Root cause analysis (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)

Travel Requirements:

5 to 10% Domestic/International Travel

Salary Range:$111,000 - $156,133 a yearCompensation & Benefits:

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus 
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Flexible Vacation Policy
• Generous paid holiday schedule and winter break 

ADDITIONAL U.S. BENEFITS:

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity insurance
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• Well-being reimbursement
• Paid leave benefits for new parents
• Paid time off to volunteer
• On-site, no-cost fitness center at our U.S. headquarters

Additional Information:

Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law.

 

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

 

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