Sr. Engineer, Device Development (Somerville)

Reference: 629197Posted: 2026-07-22Location: Cambridge, MassachusettsCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on apply.placed-app.com SummaryThis position will serve the role of medical device development engineer within Pharmaceutical Development. Experienced engineer who executes technical development of drug delivery medical devices and packaging. The role includes but is not limited to determining design input, generating design outputs, conducting design verification and validation, developing manufacturing and inspection processes, supporting GMP manufacturing of clinical trial material. This individual will execute assigned project activities and work with project team members to develop and manufacture the combination products. They may oversee the execution of project tasks and monitor the activities and deliverables of project aspects in a leadership role. The position is set in a dynamic and fast-paced environment.Critical areas of focus will be mechanical design, testing, risk management activities, technical transfers, scale-up and new process development.Principal Duties And Responsibilities Include The FollowingDesign medical device mechanical components and packaging.
Perform Design Failure Mode and Effects Analysis (DFMEA) and User Failure Mode and Effects Analysis (UFMEA)
Lead design verification and validation (V&V), design outputs (drawings, specs), and feasibility assessments, including prototyping and lab testing.
Collaborate with Quality, Regulatory, Human Factors, and Manufacturing teams, often managing relationships with external CMOs/suppliers.
Author technical documentation to ensure compliance with FDA, EU, and ISO standards
Communicate project plans, status updates and progress against milestones to project team members including management
Generate technical documents including test protocols and reports documenting product and process knowledge
Display a strong understanding of product development and transfer needs of commercial developmentQualification RequirementsMinimum of a bachelor’s degree (advanced degree desirable) in Mechanical Engineering, Biomedical Engineering or related discipline
8+ years of experience in medical device design, development and testing
Strong knowledge and understanding of medical device design controls and product realization processes.
Strong knowledge of ISO 13485, ISO 14971, IEC 62366
Experience using 3D modeling software such as SolidWorks or ProEngineer
Capital project experience, including authoring User Requirement Specifications for processing equipment, vendor proposal selection, design review and Factory Acceptance Testing
Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluate processes and develop practical solutions to technical challenges
Use of DoE and associated statistical methods for process and design space optimization
Demonstrated written and verbal communication skills
Demonstrated data analysis and problem-solving skills
High degree of initiative and self-motivation to meaningfully advance multiple tasks and projects
Strong interpersonal skills
Experience solving ambiguous problems
Experience creating technical, written content
A hard-working, team-player that is passionate about science and can effectively collaborate in a dynamic, cross-functional matrix environment
Geometric Dimensioning and Tolerancing (GD&T) practices
Ability to interpret and draft technical drawings and schematics
Experience designing and developing mechanical assemblies
Strong understanding of mechanical engineering principles and methodologies
Experience in plastic part design, extrusion techniques and injection molding
Familiarity with best practices for implementing automated systems (e.g. GAMP)
Drafting of regulatory submission documents and agency audit experience
Working Conditions:
Production Floor – gowning requirements
Bending
Lifting