Senior Product Engineer

MVE Biological Solutions is the leading global manufacturer of vacuum insulated products and cryogenic systems. More than 50 years ago, they  set the standard for storage of biological materials at low temperatures. Today, they continue to exceed these standards. Industries from around the world look to MVE for excellence and innovation. Their solutions empower industries to better utilize cryogenic technology. In this manner, MVE continues to make a vital contribution in today’s biomedical life sciences industry.

Position Summary:
The Senior Product Engineer will lead initiatives across the full product lifecycle, from conception through commercialization and sustaining at MVE Biological Solutions New Prague, Minnesota location. This hands-on role requires expertise in mechanical design, system integration, prototype fabrication and testing, and process development. This role will help teams define and achieve the objectives and goals required to complete projects on time and within budget, mentor junior engineers (levels I and II), and spearhead collaboration with cross-functional teams. The ideal candidate will thrive in diverse work environments, including office, laboratory, and manufacturing settings, possess strong management and leadership skills and a deep understanding of product engineering principles to drive innovation and maintain product excellence.

Responsibilities include, but are not limited to:

• Analyze and optimize designs for functionality, reliability, and manufacturability using computer-aided analysis and classical engineering techniques to ensure compliance with requirements
• Plan, evaluate, and execute activities related to new product concepts, design changes, product improvements, and value improvement initiatives
• Lead and collaborate with cross-functional teams and external resources to manage all stages of product development and engineering changes, ensuring clear communication with stakeholders and proper documentation per MVE's internal procedures
• Translate customer needs and specifications into detailed mechanical designs
• Develop and implement systems and processes to enhance product quality, improve customer value, and promote adherence to safety and quality standards
• Manage projects to ensure timely delivery, budget compliance, and return on investment (ROI)
• Provide technical leadership and mentorship to junior engineers
• Prepare, review, and communicate Engineering Change Requests (ECRs) or Temporary Design Deviations (TDDs) to stakeholders
• Conduct informal and formal design reviews, as well as design verification and validation testing, and risk management activities
• Investigate quality deviations through studies to determine root causes and implement corrective actions
• Evaluate non-conformances or field failures and implement corrective actions or design improvements
• Support the regulatory team with medical device registrations (e.g., MDD/MDR, FDA, CFDA) by providing engineering expertise
• Manage product costing and maintain Bills of Materials (BOM) within the document management system
• Assist internal and external teams in troubleshooting technical issues
• Adhere to safety protocols and company policies at all times
• Accomplishes engineering and organization mission by completing related results as needed

Qualifications (Minimum Requirements):

• Demonstrated ability to communicate effectively and lead within a cross-functional team environment
• Extensive experience in solving complex problems through innovative designs, adhering to Design Control and Change Control processes
• Extensive experience of problem-solving methodologies, including PDCA (Plan-Do-Check-Act), 5 Why's, and Ishikawa (Fishbone) analysis
• Extensive knowledge of classical mechanical engineering principles such as GD&T (Geometric Dimensioning & Tolerancing), DFM (Design for Manufacturability), RCCA (Root Cause and Corrective Action), and Failure Mode and Effects Analysis (FMEA)
• Extensive knowledge in Engineering Change Orders, New Product Development process, Design Verification & Validation, and Design Transfer,
• Proven experience with 3D modeling and finite element analysis using CAD tools such as SolidWorks
• Proven experience with statistical analysis tools and methods, including Minitab, ANOVA, and DOE (Design of Experiments)
• Proven experience in utilizing software applications such as MS Word, Excel, PowerPoint, and SolidWorks for engineering tasks
• Working knowledge of regulatory standards and compliance requirements, including ISO 13485, ISO 14971, EU MDR (Regulation (EU) 2017/745), and FDA Good Manufacturing Practices (GMP)

Preferred Skills:

• Extensive knowledge of MIG/TIG welding techniques, sheet metal fabrication, cryogenic technology, vacuum systems, and/or assembly work.
• Familiarity with Lean manufacturing principles and their application in engineering processes

Professional Experience:

• A minimum of 7 years’ experience in product development in a regulated industry: medical device (preferred), pharmaceutical, aerospace, automobile, etc, with a proven track record of successful project delivery

Education Requirements:

• Bachelor’s Degree or higher in Mechanical Engineering, Biomechanical Engineering or equivalent related disciplines

Personal Attributes:  

• Effectively communicate technical concepts to non-technical stakeholders and foster collaboration across cross-functional teams.
• Self-motivated with the ability to work independently and as part of a team
• Promote a culture of teamwork, knowledge sharing, and professional development
• Commitment to continuous learning
• Passion for, and alignment with MVE’s mission, vision, values & operating principles
• Passion for working in a values-based company in alignment with a learning organization
• An individual who brings strong core values, quality, ethics, and integrity
• A collaborative team player who embraces and champions the culture
• Strong work ethic and ability to deliver results
• Meet commitments in a dynamic environment
• Welcoming of differing views and opinions
• Exceptional organizational and planning skills, strong analytical abilities, and process orientation
• Desires to own decisions and take responsibility for outcomes
• Willingness to travel when required
• Willingness to continually embrace personal and professional development

Physical Work Environment Will Require: 

• Ability to work in an office, laboratory, and manufacturing settings environment 
• Ability to move around an office, lab, and production floor to address production issues relating to products and equipment 
• Ability to sit, stand, and/or walk for 8 hrs/day 
• Occasional lifting of up to 50 lbs., occasional heavier lifting