NPI Manufacturing Engineer, Senior

Socket.dev; Saint Paul (MN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

Time off programs

Annual bonus program

Job summary

Forj Medical in Saint Paul, MN seeks a Senior Manufacturing Engineer to lead NPI for complex electro-mechanical medical devices. You will collaborate early with development engineering to design for manufacturability and guide transfers from pilot builds through full production ramp, owning build, delivery, documentation, and continuous improvement while mentoring the Manufacturing Engineering team.

You will manage production across multiple product lines, keep the issues list current, interact

Qualifications

• Bachelor's degree in engineering, technical, or scientific discipline.
• 6+ years manufacturing engineering experience in an electronic-based manufacturing environment.
• Demonstrated experience leading new product introduction / design transfer for complex electromechanical devices
• Demonstrated experience with regulated environments such as FDA QSRs and ISO 13485 for medical devices
• Proficiency with quality improvement tools and techniques
• Proficiency with writing and editing production and other technical documents
• Strong interpersonal communication skills
• Strong analytical skills and problem-solving ability
• Ability to both work independently and function as a team member and ability to lead and drive cross-functional teams
• Proficiency working with the Microsoft Office productivity suite

Responsibilities

• 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 Manufacturingon cross-functional NPI core teams, providing design input, status updates, and flagging risks to program timelines and/or device cost.

Skills

Quality tools

Technical writing

Communication

Problem solving

Team leadership

Microsoft Office

Education

Bachelor's degree in engineering

Master's degree in STEM field

Tools

DFM/DFA

Quality documentation tools

Job description

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary

The 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 Responsibilities

New 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 Manufacturingon 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.

Qualifications

Required

• 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

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Employment Requirement

Must be authorized to work in the United States.

Compensation and Total Rewards Package

The 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.