Lead Manufacturing Engineer

Medasource; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Medasource in Madison, WI seeks a Manufacturing Quality Engineer to ensure quality, compliance, and process safety on-site. The role collaborates with manufacturing and production teams to uphold standards.

We target a mid-level candidate with 5+ years of experience, but will consider a more senior or lead-level engineer with deep fluency in manufacturing quality. This is a full-time, direct-hire role on the production floor.

Qualifications

• Minimum of 5 years of experience in manufacturing quality or related engineering with deep QA responsibilities.
• On-site presence in Madison, Wisconsin, with hands-on work on the production floor.
• Strong mechanical, electrical, or software hardware literacy for troubleshooting physical products.
• Pragmatic, collaborative problem solver able to work with cross-functional teams.
• Willingness to travel internationally if required in the future.

Responsibilities

• Process validations: review, guide, and approve validation plans and execution.
• Final product release: own release process and review batch records for regulatory compliance.
• Process change management: approve changes with robust qualification activities.
• Product disposition & rework: determine rework feasibility and manage scrap procedures.
• CAPA & root-cause investigations: lead or assist investigations and verify corrective actions.
• SOPs & documentation: author SOPs and mentor teammates in compliant procedures.
• Auditing & compliance: partake in external audits and internal quality audits.

Skills

Manufacturing quality

Process validation

CAPA investigations

Cross-functional collaboration

Troubleshooting hardware

Job description

We are seeking a highly motivated, pragmatic Manufacturing Quality Engineer to join our team on-site in Madison, Wisconsin. Nominally targeted at a mid-level candidate with a minimum of 5 years of experience, we have the flexibility to bring on a more senior or lead-level engineer who possesses deep fluency in manufacturing quality.

In this critical role, you will be one of only one handling this specialty on our team. You will act as a collaborative partner to our manufacturing and production teams, ensuring the highest standards of quality, compliance, and process safety. This is a full-time, direct-hire role; we are looking for dedicated individuals committed to growing with our team over the long term, not short-term consultants.

Key Responsibilities

• Process Validations: Collaborate closely with manufacturing engineers and the production team to review, guide, and approve process validation plans and execution.
• Final Product Release: Take ownership of the final product release process, meticulously reviewing batch records and other manufacturing documentation to ensure completeness, accuracy, and regulatory compliance before products are released for customer use.
• Process Change Management: Review and approve manufacturing process changes, ensuring that all necessary qualification and verification activities are robustly executed to maintain process integrity.
• Product Disposition & Rework: Assist in dispositioning rejected products, determining whether failing components/products can be safely reworked, reviewing specific rework protocols, and overseeing proper scrap procedures when necessary.
• CAPA & Root Cause Investigations: Lead or assist in robust root-cause investigations for product and process non-conformances, implementing and verifying the effectiveness of corrective and preventive actions (CAPA).
• SOPs & Documentation: Author clear Standard Operating Procedures (SOPs) and guide or mentor other team members in drafting compliant, practical manufacturing procedures.
• Auditing & Compliance: Represent the company during external regulatory audits and actively participate in or conduct internal quality audits.

Role Requirements

• Experience: Minimum of 5 years of experience in manufacturing quality, or a prolonged tenure in an adjacent engineering role with an in-depth understanding of a manufacturing quality engineer's responsibilities.
• On-Site Presence: Must be fully on-site daily in Madison, Wisconsin. You will spend significant time on the production floor, physically handling hardware, and working side-by-side with production technicians to troubleshoot issues in real time.
• Technical Hardware Literacy: Strong mechanical, electrical, or software hardware literacy. You must be comfortable troubleshooting physical products and understanding how mechanical and electrical components are built and integrated.
• Pragmatic Mindset: A highly collaborative and solution-oriented approach. We need an engineer who sits down with cross-functional teams to help find compliant, business-friendly solutions to meet organizational needs.
• Hands-on Motivation: A high level of motivation and a willingness to get your hands dirty in a fast-moving, evolving startup culture.
• Travel Capability: Must have valid documentation and the capability to travel internationally if the role/organization expands in the future. (Routine day-to-day travel is minimal to none, estimated under 10%).

Preferred Qualifications (Nice-to-Haves)

• Medical Device Background: Highly preferred. Hardware-based medical device experience is a major bonus.
• Adjacent Regulated Hardware Experience: Aerospace or automotive backgrounds are highly welcome, provided you can successfully transition from a high-volume mindset to a low-volume, high-complexity environment. (Please note: Candidates with strictly pharmaceutical backgrounds who lack experience with physical mechanical, electrical, or software components may find themselves less aligned with our specific hardware environment).
• Auditing Certification: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is highly helpful, though not strictly required

Work is primarily performed in an office and light-manufacturing/lab environment at the Madison, WI facility. The role requires the ability to sit or stand for extended periods, use a computer workstation, and occasionally lift up to 25 lbs. Reasonable accommodations will be made for individuals with disabilities to perform essential job functions.