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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical device engineering, focusing on design controls, risk management, and regulatory compliance. Proven ability to lead teams in product development and commercialization while optimizing manufacturing processes.
Highest-signal resume keywords
Design ControlsRisk AnalysisQuality Management SystemsRegulatory ComplianceMedical Device Engineering
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Design Verification TestingProcess ValidationInjection MoldingAutomationComplex AssemblyPackaging OperationsDrug-Delivery SystemsCombination ProductsDevice Risk ManagementCommercial Manufacturing
Soft Skills
Problem SolvingCollaborationLeadership
Tools & Technologies
ISO 13485ISO 14971-2019
Industry Keywords
Medical DevicesPharmaceutical EngineeringBiologic EngineeringCombination ProductsGlobal Commercialization
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Build engineering capabilities related to medical devices and combination products
- Manage internal and external manufacturing through development, scale-up, commercialization, and design transfer
- Support complex drug-delivery systems including autoinjectors, ophthalmic products, and inhalation products
- Serve as a technical subject matter expert on device components, combination products, and processes
- Support global commercialization and technology transfer activities
- Drive product robustness for sustained launch while maintaining quality and regulatory compliance
- Develop solutions using design controls, design transfer, control strategies, device risk management, and design verification testing
- Support internal and external component and combination product manufacturing globally
- Identify issues, determine root causes, and provide solutions
- Optimize design and manufacturing using engineering best practices and tools
- Support regulatory agency responses and pre-approval inspections
- Develop and execute technology-transfer and problem-solving plans
- Lead teams in late development stages and collaborate with internal and external partners
- Build strategic partnerships with manufacturing sites and partner groups
- Support regulatory inspections and maintain compliance with quality management systems
Requirements
What you’ll need- Bachelor's degree in mechanical engineering, biomedical engineering, or a related technical field required
- Minimum of 5 years of experience in pharmaceutical, biologic, medical device, or combination product engineering
- At least 2 years supporting commercial manufacturing
- Expertise in design controls, risk analysis, control strategies, design verification testing, and process validation
- Strong understanding of quality management systems and regulatory compliance
- Technical experience in injection molding, automation, complex assembly, and packaging operations for medical device or combination product component manufacturing
- Direct experience in autoinjectors, ophthalmic products, or inhalation products highly preferred
- Proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems
- Must be a US or Puerto Rico resident
- No visa sponsorship available
- Ability to travel 10%
- Regular employee status
- No relocation provided
- Valid driving license is not required
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Hybrid work arrangement