VentureMedGroup is currently looking for an Operations Engineer (EIII)

About Us:

VentureMedGroup is a fast-growing MedTech innovator advancing vascular and endovascular care. Founded by vascular surgeon Dr. John Pigott, the company developed the FLEX Vessel Prep™ System, a minimally invasive, non-balloon endovascular tool designed to optimize vessel preparation and improve outcomes in AV fistula, graft, and peripheral interventions. Backed by a seasoned leadership team with multiple MedTech scale-and-exit successes, VentureMed is entering a major commercial growth phase—expanding nationally and building its clinical and reimbursement infrastructure.

Why You’ll Love It

● Join an experienced leadership team with deep vascular and endovascular expertise and a proven track record of building and exiting successful MedTech companies.

● Help advance a first-in-class technology with strong clinical evidence, FDA clearance, and active reimbursement momentum through a current TPT designation.

● Play a foundational role in supporting VentureMed’s commercial organization—building process, culture, and impact in a company on the rise.

Position Overview:

The Operations Engineer (EIII) is responsible for sustaining and improving commercial medical device manufacturing processes across internal and contract manufacturing sites. This role provides hands-on engineering support to production, leads and owns segments of root cause investigations (including NCMR and CAPA activities), executes bench testing and validation activities, and drives continuous process improvements to ensure product quality, compliance, and operational efficiency.

This individual operates in a fast-paced, cross-functional environment and plays a key role in maintaining product performance, regulatory compliance, and cost-effective manufacturing.

This role is onsite in Plymouth, MN. No sponsorship or relocation will be provided.

Major Responsibilities:

• Provide daily technical support to manufacturing and contract manufacturing sites.
• Troubleshoot production issues and implement timely corrective actions.
• Lead and own segments of root cause investigations related to NCMRs, CAPAs, customer complaints, and supplier quality issues.
• Utilize structured problem-solving methodologies (5-Why, Fishbone, statistical analysis) to identify root cause.
• Design and execute bench testing to evaluate product or process performance.
• Analyze data using Excel, Minitab, or similar tools and document findings in formal technical reports.
• Author and update work instructions, SOPs, test methods, validation protocols, and engineering change documentation.
• Ensure compliance with FDA Quality System Regulations (21 CFR 820), ISO 13485, and internal quality requirements.
• Drive continuous improvement initiatives to improve yield, cost-of-goods, manufacturability, and process robustness.
• Collaborate cross-functionally with Manufacturing, Quality, Regulatory, R&D, and Supply Chain teams.
• Support product development transfers to manufacturing and scaling production activities.
• Participate in weekly operational reviews and communicate risks, challenges, and progress clearly to leadership.

Qualifications:

Education:

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial Engineering, or related engineering discipline required.

Experience:

• Minimum 5 years of experience in medical device manufacturing and/or process development.
• Hands-on experience supporting production in a regulated manufacturing environment.
• Demonstrated experience leading or contributing to NCMRs, CAPAs, and root cause investigations.
• Experience with manufacturing sustaining engineering and process improvement initiatives.
• Experience working with contract manufacturers preferred.
• Experience supporting product transfer to manufacturing preferred.

Technical Skills:

• Strong understanding of engineering fundamentals and manufacturing processes.
• Statistical knowledge and experience analyzing data sets.
• Proficient in Microsoft Office (Word, Excel required).
• Experience with Minitab or similar statistical software preferred.
• CAD experience (SolidWorks or equivalent) preferred.
• Familiarity with FDA QSR and ISO 13485 requirements.

Additional Competencies:

• Strong analytical and structured problem-solving skills.
• Clear technical writing and documentation ability.
• Ability to manage multiple priorities independently.
• Strong communication and cross-functional collaboration skills.
• Comfortable working in a fast-paced, growth-stage organization.
• Ability to travel up to 25% as needed.