Enter a job title or keyword
Senior Product Lifecycle Engineer (Medical Devices)
Job Location:
Job Location:
Cincinnati, OH - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
1 August 2026 (30+ days ago)
Posted:
Application Deadline:
29 October 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Role Description
- 7 years of engineering experience in the medical device or other regulated industries.
- Experience leading cross-functional technical projects.
- Experience with:
- Component development
- Supplier qualification
- Design verification
- Manufacturing validation
- Strong understanding of:
- Design controls
- Change management
- Risk management
- Process validation
- Quality system compliance
Must-Have Technical/Functional Skills
- Strong expertise in:
- Medical Device Product Lifecycle Management (PLM)
- Design Controls
- Engineering Change Management (ECO/ECN/ECR)
- Hands-on experience with:
- Design Verification & Validation (V&V)
- Test method development
- Protocol development
- Technical documentation
- Deep understanding of Risk Management methodologies:
- ISO 14971
- DFMEA
- PFMEA
- Hazard analysis
- Knowledge of:
- Quality Management Systems (QMS)
- ISO 13485
- FDA 21 CFR Part 820/QMSR
- Regulatory compliance requirements
- Experience in:
- Supplier Quality Engineering
- Component qualification
- Supplier development
- Design for Manufacturability (DFM)
- Proficiency in:
- IQ/OQ/PQ process validation
- Pilot builds
- Validation builds
- Manufacturing transfer
- Ability to interpret:
- Engineering drawings
- GD&T
- Tolerance stack-ups
- Specifications
- Acceptance criteria
- Strong root cause analysis and problem-solving skills using:
- 8D
- CAPA
- 5 Why
- Fishbone
- Corrective action methodologies
- Excellent project management skills including:
- Project planning
- Scheduling
- Risk management
- Stakeholder management
- Cross-functional coordination
- Strong leadership communication and influencing skills with the ability to drive decisions without direct authority.
Roles & Responsibilities
- Lead multiple high-priority lifecycle change projects from concept through implementation.
- Develop and manage:
- Project plans
- Timelines
- Risk mitigation strategies
- Implementation readiness
- Coordinate cross-functional teams across:
- Engineering
- Quality
- Regulatory
- Manufacturing
- Supply Chain
- Procurement
- Operations
- External suppliers
- Serve as the technical interface with suppliers for:
- Component development
- DFM reviews
- Tooling readiness
- Process capability
- Component qualification
- Support Design Verification & Validation activities:
- Test planning
- Test execution
- Data review
- Technical documentation
- Partner with manufacturing sites on:
- IQ/OQ/PQ validation
- Pilot builds
- Validation builds
- Production launch readiness
- Apply expertise in:
- Design controls
- Engineering change management
- Risk management
- Quality systems
- Regulatory compliance
- Review:
- Engineering drawings
- Specifications
- GD&T requirements
- Tolerance analyses
- Component acceptance criteria
- Drive:
- Root cause analysis
- Technical problem solving
- Timely issue resolution
- Communicate:
- Project status
- Risks
- Decisions
- Recommendations to stakeholders and senior leadership
- Demonstrate:
- Ownership
- Accountability
- Urgency
- Ability to influence without direct authority
Generic Managerial Skills
- Strong verbal and written English communication skills.
- Ability to understand customer requirements and respond accurately.
- Excellent multitasking and prioritization skills.
- Ability to work effectively in a fast-paced environment.
- Ability to understand and follow complex written procedures.
- Strong teamwork and collaboration skills.
- Sound decision-making and analytical problem-solving abilities.
- Good situational judgment and stakeholder management skills.
