Associate Mechanical Engineer (Onsite)
About The Position
Kickstart your engineering career in a dynamic, fast-paced medical device manufacturing environment. As an Associate Mechanical Engineer, you’ll collaborate with cross-functional teams to drive product and process improvements, support innovative manufacturing initiatives, and lead root cause investigations to enhance quality and performance. This hands-on role offers the opportunity to design and execute engineering tests, work with advanced electro-mechanical systems, and contribute to impactful projects from concept through implementation. Ideal for motivated, detail-oriented engineers eager to learn, grow, and make a meaningful impact on cutting-edge healthcare products. We are looking for a self-motivated Associate Mechanical Engineer to join the US Manufacturing team. This is an entry level position in which the individual will be responsible for working with team members on identifying and implementing improvement projects to support our US manufacturing operations. Additionally, this position will be highly engaged in leading root cause analysis of product failures to identify appropriate improvements and make them actionable. The person in this position will also be required to design, execute and report on engineering tests, for both feasibility and product verification. The candidate must have a strong engineering background with the ability to quickly understand electro-mechanical assemblies and a track record of delivering results on cross functional development and project teams. The optimum candidate has a BS in Mechanical Engineering or related discipline.
Requirements
- Bachelors of Science in Mechanical Engineering or related field.
Nice To Haves
- Experience with design verification and validation and engineering study design
- Experience with component design and material selection
- Experience with organized root cause analysis (5 whys, is/is not, Ishikawa, etc)
- Experience with formal Risk Management tools including Preliminary Hazard Analysis (PHA), System Hazard Analysis (SHA) and Failure Mode and Effect Analysis (FMEA).
- Demonstrated excellent project team skills as part of a cross-functional team that includes development/procurement/manufacturing/regulatory and quality experts.
- Cross functional team leadership experience a plus.
- Experience with continuous improvement methods and toolsets such as Six Sigma, Kaizen, CTQ and Critical Parameter Management. Six Sigma Green Belt or Black Belt certification is a plus.
- Working knowledge of medical device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).
- Statistical Analysis (t-test, tolerance interval, confidence interval, ANOVA). Familiar with Minitab and/or JMP.
- Working knowledge of Computer Aided Design & Finite Element Analysis. Advanced knowledge a plus
- Formalized problem solving (Cause and Effect, A3, 5 Whys8Ds, DMAIC, PDCA).
- Ability to learn and adapt quickly in a fast paced dynamic environment
- Ability to identify, organize, and judge priorities and make recommendations to management.
- Basic project management skills (advanced skills a plus)
- Ability to communicate and collaborate within a cross functional project team.
- Ability to present and communicate clearly and confidently to multiple levels of an organization.
Responsibilities
- Design iterations of existing materials or products to improve quality, service, and cost
- Design and set up feasibility tests to evaluate concepts, new materials and components
- Support/lead cross functional teams as a mechanical engineering representative and/or project leader depending on project scope
- Develop/execute engineering project plans to burn down risks and optimize resource utilization
- Lead and support root cause analysis for product failures and other issues
- Author product qualifications test and report results
- Design test fixtures for product qualification using CAD and/or other technologies
- Interface with external suppliers, consultant, experts, as needed
- Review documents and engineering change orders and maintain documentation control prior to release.
- Liaison cross functionally with stakeholders to drive alignment with project goals.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
