Combination Product Engineer III

Alnylam Pharmaceuticals • Cambridge, MA

4d • Hybrid

About The Position

The Combination Product Development Engineer III is a key member of the Combination Product Development (CPD) team.
CPD develops and maintains Alnylam combination products and device platforms. CPD directly manages the entire design and development process for clinical and commercial phase combination products. This includes selection and evaluation of primary container systems, components, and device constituent parts. During development, CPD creates and maintains the DHF and risk management file, performs all engineering characterization and design verification studies, supports the development of combination product manufacturing process, and performs or manages human factors engineering activities for all Alnylam combination products in all phases of the product lifecycle. Further, CPD collaborates to design and evaluate packaging for Alnylam combination products. The CPD team is also responsible for managing the post-production and post-market lifecycle phases of Alnylam combination products.
Members of the CPD team work collaboratively across a variety of cross-functional partners to meet design and development timelines and mitigate risk. Furthermore, the CPD team partners with other teams to support regulatory filings and responses, manage internal and external changes impacting the combination product, support complaint handling, and support implementation of robust manufacturing processes at CMP.
This position is hybrid and will be primarily located at Cambridge, MA.

Requirements

• Bachelor’s degree, preferably in engineering or life sciences.
• 5+ years related experience:
• In assessment, development and/or manufacture of combination products
• In design controls, documentation, specification development, and risk management
• Handling projects with external vendors and contract manufacturers
• In project management tools like Smartsheet, MS Project etc.
• Rigorous documentation and English written language skills, e.g., test results, reports, requirements, and specifications
• Must have excellent interpersonal skills
• Ability to work in cross-functional teams
• Ability to work independently with some oversight
• Ability to contribute to discussion of appropriate path forward with partners and stakeholders

Responsibilities

• Support execution of combination product development programs by coordinating cross functional activities and working with an external device partner to deliver project milestones:
• Develop and maintain integrated project plans (scope, timelines, dependencies, risks) across device constituent, and system-level activities; track progress and escalate issues as needed
• Coordinate day-to-day interactions among internal functions (Combination Product Development, Combination Product Quality Assurance, Regulatory, CMC, External Manufacturing Organization, etc. to ensure aligned execution)
• Serve as the project point of contact with the external device manufacturer, supporting meeting coordination, deliverable tracking, documentation exchange, and issue resolution
• With guidance from manager:
• Contribute to development of Design control activities, including Design and Development planning and reporting, Combination Product components evaluation and selection, development of requirements and specifications, design transfer activities, and design verification planning and reporting through ownership of individual deliverables
• Contribute to Risk Management for Alnylam’s Combination Products including Use, Design, and Process Risk Assessments across Vendors and CMOs, and Post-Launch Risk Management activities through ownership of individual deliverables
• Contribute to Human Factors Engineering efforts for Alnylam’s Combination Products including formative and summative evaluations through ownership of individual deliverables
• Support component and manufacturing assembly process changes
• Engage with and manage external vendors supporting Combination Product Development
• Assist resolving findings of internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues.
• Engage with cross-functional partners to support Alnylam’s portfolio
• Contribute to development and updates of Combination Product QMS documents and templates
• Remain up to date with current regulations, industry guidance, and practices for consistent best practices for combination product development and ensure implementation with Alnylam combination product development projects.

Benefits

• comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees