Manufacturing Engineer, Senior - North

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Arden Hills, MN, USA
In-Office
100K-130K Annually
Senior level
Hardware • Healthtech • Manufacturing
The Role
Own sustaining engineering and manufacturing support for assigned medical device product lines. Lead root-cause investigations, yield improvement, production troubleshooting, product transfers, technical documentation, IQ/OQ validation support, and quality issue resolution. Mentor manufacturing engineers, drive Lean Six Sigma continuous improvement, support electronic test systems, and collaborate with development engineering, Quality, customers, and suppliers in a regulated ISO 13485 and FDA QSR environment.
Summary Generated by Built In

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 owns sustaining engineering and day-to-day manufacturing support for the Forj product lines where the higher-volume production runs are supported. This is a fast-paced, hands-on role for someone who goes deep rather than wide: instead of spreading across many programs, you'll take ownership of a focused set of processes and drive them from good to great — for example, moving a line from a 95% yield to 98–99%.

Beyond the technical work, this is a senior role with a real people-mentorship component. You'll be expected to mentor and guide other engineers on the team, represent our Manufacturing group in our daily tier meetings and production structure, and — as the group grows — have the opportunity to work across other product groups.


Key Responsibilities

Sustaining Engineering & Yield Improvement

Own sustaining engineering for an assigned set of product lines, with a focus on depth over breadth — driving a smaller number of processes to significantly higher yield and stability rather than lightly touching many.

Lead root cause investigation, troubleshooting, and corrective action for recurring production and test issues.

Support and troubleshoot electronic test systems and test software across multiple test platforms and programs (a basic working knowledge of test software is expected; deep software development experience is not necessary).


Design & Product Transfers

Partner closely with development engineering to support the transfer of new and updated products into production, including during periods of elevated transfer volume.

Create, update, and maintain transfer-related documentation: assembly documentation, assembly and test procedures, part drawings, and engineering change orders (ECOs).


People Leadership & Mentoring

Mentor and coach other Manufacturing Engineering team members, helping guide their technical growth and problem-solving approach.

Actively participate in and help drive our tier meeting structure and daily production cadence.


Continuous Improvement

Lead continuous improvement initiatives using Lean Six Sigma tools and methodology to hit established CI goals.

Stay current on medical device manufacturing requirements and emerging test and process technologies.


Quality Integration & Compliance

Own quality documentation for assigned product lines, including familiarity with IQ/OQ validation work.

Partner directly with Quality Engineering to quickly troubleshoot and resolve quality issues arising on the line.





Cross-Functional & Customer Support

Work directly with customers and suppliers as needed on technical requests or specialized product needs.


Qualifications

Required:

  • Bachelor's degree in engineering, technical, or scientific discipline.
  • Medical device background, including familiarity with IQ/OQ validation work.
  • 6+ years of manufacturing engineering experience in an electronic-based manufacturing environment, with a background in electronic test or test software.
  • Demonstrated experience with regulated environments such as FDA QSRs and ISO 13485 for medical devices.
  • Demonstrated ability to drive measurable process/yield improvement (e.g., taking a process from the mid-90s% yield into the high 90s%).
  • Familiarity with Lean Six Sigma tools and methodology.
  • Proficiency writing and editing production and other technical documentation.
  • Strong interpersonal and communication skills, including the ability to mentor and develop other engineers.
  • Strong analytical and problem-solving ability; comfortable working independently and leading cross-functional efforts.
  • Proficiency with the Microsoft Office productivity suite.

Preferred:

  • Experience at a CDMO (contract development and manufacturing organization).
  • Basic working knowledge of test system software.(deep software engineering experience not required).
  • Prior experience mentoring or informally leading other engineers.


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. 

Skills Required

  • Bachelor's degree in engineering, technical, or scientific discipline
  • Medical device manufacturing background
  • Familiarity with IQ/OQ validation work
  • 6+ years of manufacturing engineering experience in an electronic-based manufacturing environment
  • Background in electronic test or test software
  • Experience in regulated environments such as FDA QSRs and ISO 13485 for medical devices
  • Demonstrated process and yield improvement experience
  • Familiarity with Lean Six Sigma tools and methodology
  • Proficiency writing and editing production and technical documentation
  • Strong interpersonal and communication skills
  • Ability to mentor and develop other engineers
  • Strong analytical and problem-solving ability
  • Ability to work independently and lead cross-functional efforts
  • Proficiency with Microsoft Office
  • Experience at a CDMO
  • Basic working knowledge of test system software
  • Prior experience mentoring or informally leading engineers

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The Company
1,000 Employees
Year Founded: 1996

What We Do

Two proven leaders in medtech development and manufacturing have come together to create something extraordinary. Minnetronix, a trusted partner in designing and manufacturing advanced medical technology, and Intricon, an expert in components, microelectronics, and precision molding, are now Forj Medical—a united force shaping the future of lifesaving devices. With expanded capabilities, integrated processes, and a shared commitment to excellence, Forj Medical empowers medical device companies to break through barriers, shorten timelines, and make and market critical devices with confidence.

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