Staff Mechanical Engineer
Staff Mechanical Engineer
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Job Description
Position Summary
The Staff Mechanical Engineer shall produce specifications for design develop verify and validate new or modified mechanical components or systems in medicalgrade sterilization capital accessories and consumables.
Duties and Responsibilities
Under limited supervision general direction etc. and in accordance with all applicable government laws regulations and ASP policies procedures and guidelines this position:
- Deliver and drive results by participating in new product development projects either as a team member or work stream leader focused on mechanical centric design and development
- Connects by demonstrating strong collaboration with cross functional team members to ensure alignment and influencing of design concepts design inputs design outputs and design verification.
- Provides strong technical leadership on assigned projects to deliver design concepts design characterization design inputs design outputs and design verification using sound engineering principles and expertise.
- Provides guidance and mentorship to junior engineers draftsmen technicians and contractors.
- Responsible for communicating business related issues or opportunities to next management level
- Performs other duties assigned as needed
Other Duties:
- Assess project requirements
- Measure the performance of mechanical components devices and systems
- Align budgets timescales and specifications with crossfunctional stakeholders customers and management
- Use computeraided design FEA and CFD software
- Undertake relevant research
- Produce and Implement designs and test procedures with compliant GDP
- Present designs drive technical reviews and own work streams
- Write protocols reports and other QMS documentation
- Providing technical support to crossfunctional teams
- Analyze and interpret data.
Education:
Bachelors Degree Mechanical Engineering
Years of Related Experience:
List specific types of experience and years that may be required for this position such as:
- 8 year of related experience in new product development required; highly regulated industry experience preferred (e.g. Aerospace Automotive Medical Devices)
- 6 years minimum of CAD design experience required; SolidWorks preferred
Knowledge Skills Abilities Certifications/Licenses and Affiliations:
(Include any required computer skills regulatory knowledge certifications licenses languages cognitive and behavioral abilities etc.)
- Thorough understanding of Design Verification and Validation highly preferred
- Strong written and verbal communication required
- Design experience for plastics highly preferred
- GD&T working knowledge highly preferred
- Medical device product development experience highly preferred
- Fluidic Systems experience a plus
- Sterilization and/or disinfection experience a plus
- This position does not entail direct supervisory responsibilities.
- Internal interface activities will include but not limited to Quality Operations Regulatory Compliance Marketing Medical Safety Field Services and Medical Safety.
- Liaise with suppliers development partners and manufacturers to support new product development sustaining engineering and manufacturing.
Required Experience:
Staff IC
Employment Type
Full-Time
