Manufacturing Equipment Engineer

Nextern•Maple Grove, MN

About The Position

We are seeking a Manufacturing Equipment Engineer 2 to own the equipment and inspection-equipment lifecycle for our manufacturing lines — equipment specifications and drawings, preventive maintenance, fixture and tooling ownership, and the selection and qualification of new equipment, including precision dimensional metrology such as laser micrometers. The ideal candidate will have 3–5 years of experience owning production equipment, fixtures, or tooling in a regulated manufacturing environment, and will give equipment sustaining a dedicated technical owner within the Manufacturing Engineering team.

Requirements

3–5 years of engineering experience owning production equipment, fixtures, or tooling in a regulated manufacturing environment; medical device experience preferred
Experience specifying and qualifying precision metrology or inspection equipment
Experience with equipment/process validation (IQ/OQ/PQ) and test method validation (TMV), including Gage R&R methodology
Working knowledge of GD&T, mechanical drawings, and CAD review (SolidWorks or similar)
Familiarity with FDA 21 CFR Part 820 (Quality System Regulation) and ISO 13485, including design and equipment controls
Understanding of validation documentation requirements in a regulated medical device environment

Nice To Haves

Direct experience with laser micrometer / non-contact dimensional gauging systems (e.g., Mitutoyo, Keyence, LaserLinc, or similar) laser welders, HIPOT/ electrical safety equipment, Oscilloscopes, Hotbox and reflow towers and other calibration required manufacturing equipment, preferred not required
Experience building or formalizing a preventive maintenance program from an informal/ad hoc state preferred
Experience in a catheter, balloon, or similarly high-precision disposable medical device manufacturing environment preferred
CMfgE, CQE, or similar professional certification a plus

Responsibilities

Own and maintain equipment specifications, drawings, and documentation for production equipment, fixtures, and tooling; keep drawings synchronized with the as-built/as-run configuration and clear known documentation backlog items
Build and run a preventive maintenance (PM) program for line equipment in partnership with Technicians, including PM schedules and spare-parts planning, with a clear escalation split between mechanical failures (Technician-owned first) and process issues (Engineering-owned first)
Own fixture and tooling design, qualification, and lifecycle management, including revisions driven by process or product changes
Lead specification, vendor evaluation, and qualification of new inspection and metrology equipment (e.g., laser micrometers and other dimensional gauging), including measuring-range and accuracy trade-off analysis, cross-vendor comparison, and fixture compatibility
Support Test Method Validation (TMV) and equipment IQ/OQ/PQ activities, including Gage R&R studies, right-sizing validation effort to risk (CSA principles) in partnership with Quality
Maintain a prioritized equipment-sustaining backlog with a defined update cadence; escalate long-lead capital equipment and qualification needs
Partner with Manufacturing Engineering on root-cause investigations where equipment is a suspected contributing factor to scrap, yield loss, or line-down events
Other duties and projects assigned