Sr. Manufacturing Engineer

We are a trusted contract manufacturing partner delivering high-quality, complex catheter solutions used worldwide to save lives and restore patient health and vital function. Every product we design, and manufacture is approached with the highest level of care and quality, recognizing that these devices are used inside patients—possibly even our own family members.

As a fast-growing organization, we are focused on harmonization, standardization, and building a strong, unified culture. We value diversity, celebrate success, support one another through change, and invest in developing a high-performing, engaged workforce. If you thrive in a collaborative, fast-paced environment and want to contribute to meaningful medical advancements, we invite you to apply.

The Senior Manufacturing Engineer is responsible for leading and supporting manufacturing process development, transfer, optimization, and validation for complex catheter-based medical devices. This role works cross-functionally with R&D, Quality, Operations, and Supply Chain to ensure robust, compliant, and efficient manufacturing processes from prototype through commercial production.

The Senior Manufacturing Engineer plays a key role in driving continuous improvement, supporting new product introductions, and ensuring manufacturing readiness while meeting regulatory, quality, and customer requirements.

• Onsite role located in the Minneapolis area
• Occasional travel to other regional manufacturing sites may be required
• Relocation assistance is not provided

• Lead and support manufacturing process development and optimization for catheter-based medical devices
• Lead and/or support process qualification and validation activities (IQ/OQ/PQ)
• Support manufacturing process transfer from development through commercial production
• Collaborate with R&D and Quality to ensure Design for Manufacturability (DFM) and Design for Assembly (DFA)
• Develop, maintain, and improve manufacturing work instructions, routers, and controlled documentation
• Provide hands-on technical support to production to resolve manufacturing issues and improve yield, throughput, and scrap
• Lead root cause investigations and corrective actions related to manufacturing and process performance
• Support equipment selection, specification, installation, and validation
• Collaborate with suppliers and contract services to ensure robust manufacturing processes and material readiness
• Support internal, customer, and regulatory audits as needed
• Drive continuous improvement initiatives using Lean Manufacturing and data-driven methodologies
• Mentor and provide technical guidance to junior engineers and technicians
• Perform other duties as assigned

• 5–8 years of experience in a regulated medical device manufacturing environment, preferably catheter-based products
• Bachelor’s degree in Engineering, Manufacturing, or a related technical discipline, or equivalent experience
• Demonstrated experience with manufacturing process development, equipment qualification, and process validation
• Strong background in root cause analysis, statistical tools, and process optimization
• Experience working within ISO 13485 and FDA QSR (21 CFR 820) regulated environments
• Strong communication and collaboration skills across cross-functional teams
• Proficiency with common engineering and manufacturing software tools
• Ability to work onsite and spend time in manufacturing environments

• Experience supporting Class II or Class III medical device manufacturing
• Experience with catheter extrusion, bonding, forming, or assembly processes
• Familiarity with Lean Manufacturing and continuous improvement methodologies

• Competitive salary range based on market conditions, experience, and internal equity
• Eligibility for an annual performance-based bonus
• Comprehensive, low-cost health and dental insurance
• Vision insurance
• Health Savings Account with company contribution
• Short- and long-term disability coverage
• Supplemental insurance options (life, AD&D, and more)
• Parental leave
• Paid time off and paid holidays
• Minnesota Earned Sick & Safe Time
• 401(k) with company match
• Opportunities for career growth and advancement