Manufacturing Engineer, Senior - North

Forj Medical•Arden Hills, MN

44d

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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