Overview
Our creative and energized engineering team is looking for a Sr. R&D Mechanical Engineer to design and develop Analytical Instruments in the life science industries.
This individual will play a key role in our new product development projects and will develop hardware requirements and solutions for new products, as well as refining design for current products.
The work will include research, design and development of new systems and devices which will be used to control, monitor, and regulate Pharma or Biotech processes in laboratory or production environments. The individual will be involved in performing traditional mechanical engineer work from concept to fully verified and validated products in close collaboration with other engineers of different functions.
Responsibilities
- Provide innovative and creative concepts or ideas in the development of Analytical instruments for Bio/Pharma processes to satisfy product requirements.
- Produce solid models and detailed drawings of mechanical components and assemblies in SolidWorks.
- Apply engineering principles and practices to assure quality of products, such as GD&T, DOE, FMEA.
- Design and execute test plans to verify the feasibility, design, operation, or performance of components and systems.
- Interface with service engineers, scientists, and suppliers to resolve quality issues.
- Support and/or supervise transfer of new product or product modifications to manufacturing.
- Communicate suppliers and vendors with drawing specifications, tolerance, and special process steps.
- Suggest cost-saving proposals on make-versus-buy analysis or alternative sourcing.
- Collaborate within multidisciplinary teams to contribute and achieve projects milestones or goals.
Qualifications
Education: Bachelor of Science or higher in Mechanical Engineering.
Work Experience:
- 8-10+ years of experience working with developing mechanical and/or control systems.
- Experience in instrument development in life science.
- Experience in working with regulated environments (e.g. FDA, USP, EU, GxP, ISO, CE, UL, ATEX…).
- Experience in using enterprise level software systems including MRP / ERP software, Confluence, JIRA, and SharePoint.
Skills:
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- Proficient in SolidWork 3D modeling and FEA stress, thermal, and flow simulations.
- Create/review technical drawings and conduct tolerance analysis.
- Experienced in Root Cause Analysis and implement effective solutions promptly.
- Ability to prioritize tasks and meet deadlines.
- Strong verbal and written communication skills.