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 will be responsible for leading and supporting projects and products that span the full product lifecycle, from new product design and development to product release and related sustaining activities. This is a hands-on engineering position that will require the candidate to spend time in the office, lab and on the manufacturing floor. The engineering activities associated with this position may include but are not limited to mechanical design, system integration, prototype fabrication and process development for MVE’s Life Sciences products.
Responsibilities (include but are not limited to):
- Mechanical design of new products following MVE’s five phase product development process
- Sustaining engineering activities for released products, including design improvements, reliability enhancements, manufacturing support, supplier qualification and changes, cost reduction initiatives, obsolescence management, and resolution of production and field performance issues
- Partner with manufacturing, quality, sourcing, and service teams to resolve complex product issues affecting production efficiency, product quality, and customer satisfaction
- Evaluate component obsolescence and lead redesign efforts required to maintain product availability and regulatory compliance
- Develop and guide prototype development and experimental design, ensuring alignment with strategic product goals
- Author and refine test and validation protocols to evaluate new product concepts, design iterations, performance improvements, and cost-reduction strategies
- Perform detailed tolerance stack-ups and tolerance analysis to ensure fit, function, and manufacturability of critical assemblies
- Integrate DFM and DFA principles early in the design process to reduce complexity, cost, and time to market
- Apply reliability engineering tools and methodologies to predict product life, mitigate failure modes, and improve overall system robustness
- Lead creation and maintenance of Design FMEAs, ensuring risk is identified, documented, and mitigated proactively
- Author and approve required technical documentation for existing products, new products and line extensions, ensuring compliance with regulatory and quality standards
- Collaborate with operations and quality leadership to establish robust, scalable production lines for new products
- Develop product cost models and drive BOM accuracy and optimization using enterprise document management systems
- Initiate, lead, and close out Engineering Change Requests (ECRs) and/or Temporary Design Deviations (TDDs) with cross-functional impact
- Lead formal and informal design reviews, ensuring that design verification test plans and reports meet functional, regulatory, and risk-based requirements
- Assess and resolve complex product non-conformances, driving root cause analysis and implementing corrective design actions
- Stay current with emerging technologies, industry trends, and engineering best practices, and apply advancements to improve product development processes and outcomes
- Mentor junior engineers and serve as a technical resource for advanced product and process troubleshooting
Competencies & Personal Attributes:
- Passion for, and alignment with, MVE’s mission
- An individual who brings strong core values, quality, ethics, and integrity
- A team player who embraces the culture of collaboration and accountability
- Strong work ethic and ability to deliver results and meet commitments in a dynamic environment
- Exceptional communication skills with the ability to inspire and influence others
- An individual who works efficiently, effectively prioritizes and drives corporate goals
- Exceptional organizational skills with demonstrated ability to plan and manage multiple projects concurrently, strong analytical abilities, and process orientation
- Good communication skills, both written and oral
- Ability to work well both independently and as part of an integrated team
- Willingness to travel when required
- Willingness to continually embrace personal and professional development
- Demonstrates a business process orientation to developing solutions
Qualifications and Education Requirements:
- Bachelor’s Degree or higher in Mechanical/Mechatronics Engineering or equivalent
- Minimum 6 years of full-time engineering work experience
- Must be proficient with SOLIDWORKS CAD software for mechanical design
- Demonstrated expertise creating and maintaining manufacturing-ready 2D engineering drawings, including dimensioning schemes, tolerance application, drawing notes, revision control, and inspection requirements
- Strong understanding of ASME Y14.5 GD&T principles and their practical application to design, manufacturing, and inspection
- Experience identifying Critical-to-Quality (CTQ), Critical-to-Function (CTF), and incorporating appropriate inspection requirements into engineering documentation
- Proficiency performing tolerance stack-up analyses and developing robust designs that account for manufacturing variation and assembly requirements
- Demonstrated ability to lead technical design reviews and make sound engineering decisions balancing performance, reliability, manufacturability, cost, and schedule
- Experience applying reliability engineering methods such as DFMEA, fault tree analysis, root cause analysis, accelerated life testing, reliability growth, and design-for-reliability principles
- Demonstrated experience supporting released products through sustaining engineering activities, including engineering change management, root cause analysis, reliability improvements, supplier changes, and manufacturing support
- Experience applying FEA tools to evaluate structural, thermal, and mechanical performance of engineered systems
- Experience with Design of Experiments (DOE)
- Must be proficient with Microsoft Excel and other Microsoft Office applications
- First-hand knowledge and experience in design for common manufacturing processes such as machining, welding, die casting, sheet metal fabrication, injection molding, etc.
Preferred Skills:
- Experience with cryogenics
- Experience with CFD modeling
- Familiarity with the Medical Device Directive / Regulation (MDD/MDR), ISO 13485, FDA design controls or similar medical device regulatory requirements is a plus