Mechanical or Biomedical Engineer - Medical Device
UpStream Global Services - Billerica, MA

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Mechanical or Biomedical Engineer - Medical Device

We have an immediate opportunity for an experienced Mechanical or Biomedical Engineer with Medical Device industry experience for the Billerica, MA area. The successful candidate will have an MS degree in Mechanical or Biomedical Engineering with at least 5 years of relevant experience, or a PhD degree in Mechanical or Biomedical Engineering with at least 3 years of relevant experience.

Principal Accountabilities:
- Provide technical support and expertise to manufacturing groups with regard to issue resolution, troubleshooting, and improvements to current product lines and corresponding manufacturing processes.
- Design, develop, troubleshoot, test and evaluate electromechanical instruments and systems involving precision motion control, automation technology, computer interfaces, and microscopy in order to support and improve upon current and new product platforms.
- Develop and implement modifications of processes, equipment, and facility required through the use of Lean Manufacturing based concepts to address expected increases in productivity, quality and reduction in costs.
- Assist in the development of Lean based tools and process optimization at customer kaizen events as part of the company's System Optimization initiative.
- Lead, manage and perform engineering studies and projects according to defined plans, budgets, and schedules.
- Use skills and experience to identify, develop, and establish supplier specifications and tolerances to raw materials and manufactured components.
- Troubleshoot, design and develop scripts to test and automate tasks involving microscopy products.
- Design, develop, repair, and construct mechanical components pertaining to automated instrumentation utilizing machining skills and equipment such as milling platforms, lathes, grinders, etc.
- Install, interface, maintain, and troubleshoot automated and interactive measurement and preparation equipment (strainers, spectrometers) and microscopy equipment.
- Create detailed drawings and models using CAD programs as part of the development process and communication of design ideas. Utilize sensitive measurement devices and techniques.
- Communicate project progress through written reports and formal slide presentations to management.
- Manage outsourced fabrications as needed. This includes plastic injection molding, CNC machining, and other fabrication not achievable with in-house equipment and tooling.
- Handle hazardous waste as appropriate.

- Demonstrated ability to improve device design and/or quality in current and new technologies, products, materials, processes, or equipment.
- Proficiency in planning, leading and executing product development projects within a cross functional team environment.
- Demonstrated ability to set cross functional priorities for self and team and exhibit strong accountability to achieve scheduled milestone completion of designated tasks
- Demonstrated technical leadership achieving business critical goals
- Experienced with technical product design for high volume manufacture
- Excellent communication cross functionally and within business leadership
- Demonstrated proficiency to make practical assumptions with engineering justifications, where needed
- Applies a wide variety of scientific/engineering principles and theoretical considerations
- Proficiency in creating new test methods, including fixture design, method development, measurement system analysis, and safe laboratory implementation
- History with component designs, development and analysis of complex engineering tests and experiments.
- Training and confidence level developing 3D CAD modeling (SOLIDWORKS Preferred)
- Excellent record of application of statistical methods, including generation of technical reports
- Self-initiator, results driven and action & detailed oriented.

Specific Procedures/Practices::
- Experience in phase gated product development process preferred
- Knowledge of Medical device regulations and practices a plus
- Ability to identify, break down and solve complex technical problems, and provide technical direction to others
- Design and statistical analysis of experiments
- Leverage understanding of first engineering principles, advanced engineering methods, data and judgment to influence the course of product development activities.

For immediate consideration please contact:

UpStream Global Services