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 Product Engineer supports the continued success of our stainless steel cryogenic freezer portfolio by ensuring our products remain safe, effective, and compliant throughout their lifecycle. The Product Engineer collaborates with cross-functional teams to resolve field issues, perform root cause analysis, support the technical service team, support design and process improvements, and support regulatory submissions. This work directly impacts patient outcomes and customer satisfaction. The ideal candidate will thrive in diverse work environments, including office, laboratory, and manufacturing settings, possess strong interpersonal skills and a deep understanding of sustaining engineering principles to maintain product excellence.

Responsibilities include, but are not limited to:

• Plan, evaluate, and execute activities related to design changes, product improvements, and value improvement initiatives
• Lead and collaborate with cross-functional teams and external resources to manage post-market engineering changes, ensuring clear communication with stakeholders and proper documentation per MVE's internal procedures
• Develop and implement systems and processes to enhance product quality, improve customer value, and promote adherence to safety and quality standards
• Prepare, review, and communicate Engineering Change Requests (ECRs) or Temporary Design Deviations (TDDs) to stakeholders
• Investigate quality deviations through studies to determine root causes and implement corrective actions
• Evaluate non-conformances or field failures including root cause analysis 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
• Maintain Bills of Materials (BOM) within the JD Edwards E1 ERP
• Assist internal and external teams in troubleshooting technical issues
• Adhere to safety protocols and company policies at all times

Qualifications (Minimum Requirements):

• Demonstrated ability to communicate effectively and lead within a cross-functional team environment
• Experience with problem-solving methodologies, including PDCA (Plan-Do-Check-Act), 5 Why's, and Ishikawa (Fishbone) analysis
• Knowledge of classical mechanical engineering principles such as Geometric Dimensioning & Tolerancing (GD&T), Design for Manufacturability (DFM), Root Cause and Corrective Action (RCCA), and Failure Mode and Effects Analysis (FMEA)
• Knowledge of Engineering Change Orders, New Product Development process, Design Verification & Validation, and Design Transfer
• Proven experience with mechanical 3D modeling and 2D drawing creation/modification using CAD tools such as SolidWorks
• Proven experience in utilizing software applications such as MS Word, Excel, PowerPoint, and SolidWorks for engineering tasks
• Proven experience with complaint handling and Corrective and Preventative Actions (CAPAs)
• 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:

• Familiarity with JD Edwards ERP software
• Proven experience with statistical analysis tools and methods, including Minitab and Design of Experiments (DOE)
• Proven experience working with and managing external test laboratories
• Proven experience with reliability engineering and reliability improvement
• Familiarity with Lean manufacturing principles and their application in engineering processes

Professional Experience:

• A minimum of 5 years’ experience in sustaining engineering and 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, Biomedical Engineering, Manufacturing Engineering or equivalent related disciplines

Personal Attributes:  

• Effectively communicate technical concepts to non-technical stakeholders and foster collaboration across cross-functional teams
• Self-motivated and hands-on with the ability to work independently and as part of a team
• Promote a culture of teamwork, knowledge sharing, and professional development
• Passion for, and alignment with MVE’s mission, vision, values & operating principles
• 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 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