Job SummaryThe Senior Manufacturing Engineer leads NPI for complex electro-mechanical medical devices across multiple product lines, working with development engineering early to design for manufacturability and guide transfer from pilot builds through sustaining handoff and full production ramp. This role also owns product build & delivery, documentation, cell layout, issue tracking and resolution, and continuous improvement, while coaching and mentoring the broader Manufacturing Engineering team.Key ResponsibilitiesNew Product Introduction & Design Transfer- New product transfer: Partner closely with development engineering to coordinate and manage the smooth transfer of new products into production, from initial design reviews through production release.
- Pilot build leadership: Plan and execute pilot builds for new products, defining production cell layout, staffing, and equipment needs ahead of full-scale production.
- Production readiness & DFM: Provide manufacturability (DFM/DFA) feedback to development engineering during design, and lead production readiness reviews to confirm processes, tooling, and documentation are qualified before ramp.
- Ramp-up planning: Coordinate with Production, Quality, and Supply Chain to plan and manage the ramp from production equivalent builds, pilot builds, into full production volume, tracking open issues to closure.
- Documentation lifecycle: Create, update, and maintain core production documentation, including materials build documentation, assembly and test procedures, part drawings, and engineering change orders (ECOs).
- NPI representation: Represent Manufacturing on cross-functional NPI core teams, providing design input, status updates, and flagging risks to program timelines and/or device cost.
Production Management & Support- Product line management: Manage production builds across multiple product lines, actively maintaining the issues list and driving necessary device improvements and changes.
- Team communication: Serve as the primary point of contact to keep the production team aligned and informed on production status.
- Customer interface: Work directly with customers as needed to support technical requests or specialized product needs.
Continuous Improvement (CI) & Technical Awareness- Industry and process trends: Maintain up-to-date awareness of medical device requirements and stay current on existing and emerging manufacturing processes and trends.
Quality Integration & Compliance- Quality documentation: Own and execute quality documentation requirements specific to the assigned product lines.
- Quality collaboration: Partner directly with the Quality Engineering team to quickly address, troubleshoot, and resolve any quality issues or concerns that arise on the line.
QualificationsRequired- Education: Bachelor's degree in engineering, technical, or scientific discipline
- Experience: 6+ years manufacturing engineering experience in an electronic-based manufacturing environment
- NPI background: Demonstrated experience leading new product introduction / design transfer for complex electromechanical devices
- Regulatory: Demonstrated experience with regulated environments such as FDA QSRs and ISO 13485 for medical devices
- Quality tools: Proficiency with quality improvement tools and techniques
- Technical writing: Proficiency with writing and editing production and other technical documents
- Communication: Strong interpersonal communication skills
- Problem solving: Strong analytical skills and problem-solving ability
- Team leadership: Ability to both work independently and function as a team member and ability to lead and drive cross-functional teams
- Software: Proficiency working with the Microsoft Office productivity suite
Preferred- Education: Master's degree in STEM field
- Leadership: Leadership experience in operations
- Industry: Engineering experience with medical device manufacturing
- Design collaboration: Experience with DFM/DFA and production readiness reviews
Compensation and Total Rewards PackageThe salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.
