Process Development Engineer III - Catheters

Heraeus Holding GmbH; Fridley (MN); On-site; USD 100,000 - 117,000; Full time

Job summary

Heraeus Medevio is seeking a Process Development Engineer III to lead the design, validation, and transfer of catheter manufacturing processes. You will work across teams to deliver robust processes for commercial production, mentor engineers, and drive continuous improvement on the shop floor.

The role is based in Fridley, MN with travel to White Bear Lake, MN as needed. A strong background in catheter development, DOE, and cross-functional leadership is required.

Qualifications

• Bachelor degree in Engineering or related field preferred; other qualifications may be considered.
• Minimum 5 years of relevant experience; substitutions possible for higher degrees.
• Experience with medical devices/catheters and process development desired.
• Able to communicate complex technical concepts to all audiences.

Responsibilities

• Lead process design, development, and validation for medical devices through development stages.
• Make data-driven decisions using DOE, pFMEA, DFM, and statistics.
• Develop and implement robust manufacturing processes for new products.
• Identify, procure, and install tooling/fixturing and equipment.
• Document validation protocols and engineering studies supporting decisions.
• Mentor other engineers and collaborate with technicians on the floor.

Skills

DOE

pFMEA

Statistics

Process development

Data analysis

Cross-functional

Leadership

Education

Bachelor degree in Engineering

Job description

Process Development Engineer III - Catheters

Permanent

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

Position Summary

As part of the process development team, The Process Development Engineer III will be responsible for creating robust and sustainable manufacturing processes for medical components and devices. As a Process Development Engineer III, you will provide technical leadership for the commercial release of products to production by working cross-functionally through the Medevio product development process. Success in this position requires hands-on process work, data analysis, customer communication, coordination and documentation. The ideal candidate will have a background with catheter product development and project technical leadership.

We are open to hiring at an Engineer III or Senior EIII level. This position will be based out of Fridley, MN but will require movement between both that site and the White Bear Lake, MN location.

What You’ll Do Every Day:

• Lead in the execution of the process design, development, and validation activities for medical devices through the product development process.
• Demonstrates consistent understanding in determining solutions for complex problems, process selection decisions, and technical challenges.
• Utilizes process characterization skills and tools such as Design on Experiments (DOE), pFMEA, DFM, and statistics to make data driven decisions.
• Ensure that proper technical processes are developed, implemented, maintained, and documented to successfully introduce new products into manufacturing.
• Lead new tooling/fixturing & equipment identification, procurement, and installation. Drive execution of these activities to document, qualify or verify tooling or equipment for use.
• Creates or leverages documents such as process validation protocols or engineering studies that demonstrate technical rationale for associated decision.
• Willing and able to mentor other engineers and promote a culture of feedback.
• Works collaboratively with technicians and operators on the production floor to solve technical problems.
• Establishes regional relationships and collaborates to ensure best practices utilized.
• Other duties may be assigned as required.

What We’re Looking For:

• Bachelor degree in Engineering or related technical field strongly preferred; other relevant postsecondary education, training, and experience may be considered in lieu of a Bachelor’s degree.
• Minimum 5 years of relevant experience required; 1 year of relevant experience may be substituted for a graduated degree and 3 years for a doctorate degree.
• Manufacturing or Process Development experience in one or more of the following highly desired: medical devices (delivery systems or catheters), micro-assembly, reflow, laser ablation/welding/marking.
• Demonstrated knowledge of Process Development Engineering.
• Able to make complex data driven decisions utilizing statistics.
• Experience with process validation, installation qualification, and engineering deliverables from the product development process.
• Able to identify, execute, and communicate on any technical and/or project workstreams.
• Able to communicate complex technical concepts to all audiences including senior management, production employees, and customers.
• Demonstrated ability to develop cross-functional relationships and influence to drive results.
• Demonstrates strong leadership in communicating and championing the need for continuous improvements and continued change to meet company needs.
• Must be willing and able to travel between Fridley, MN and White Bear Lake, MN sites, as needed.

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $100,000 and $117,000 based upon a full-time schedule. This is a good faith estimate on the applicable range. Base salaries are determined by taking a variety of factors in account, including, but not limited to, candidate qualifications, geographic locations, market conditions and internal equity. This position is bonus eligible, with a target bonus of 10%. Our total compensation package includes eligibility for comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, education reimbursement, paid parental leave and paid time off.

Heraeus is proud to be an employer that provides equal access to opportunities for all its employees. We provide fair and equal consideration to all qualified applicants, regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected veteran status, age, or any other legally protected characteristic. A diverse and inclusive culture is at the heart of our Vision, Mission, and Values. We are dedicated to cultivating a workforce that reflects a broad spectrum of cultures, backgrounds, and perspectives.

We participate in E-Verify to confirm employment eligibility after hire. Learn more at www.e-verify.gov

Any further questions?

If you need any assistance or have questions, please contact [e-mail] or visit our website at jobs.heraeus.com.