Job Description

• Hands on Laboratory Experience in a GLP Setting- 1+ years of experience.
• Good Communication and Technical Writing Skills
• Ability to Multitask
• Must have BS degree Mechanical or Biomedical Engineering, or related field.

• Test procedure development and functional test execution
• Authoring technical plans and reports
• Performing statistical data analysis
• Supporting technical assessments and root cause investigations
• Transfer of information to manufacturing sites, engagement with suppliers
• Maintenance of Design History File content consistent with Good Documentation Practices

• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
• Plans and conducts work requiring judgment in the independent evaluation, selection, and adaptation and modification of standard techniques/procedures/criteria, and devises new approaches to encountered challenges.
• Generates and maintains design specifications, protocol and report writing, prototyping, design of experiments/statistical process control product optimization, design verification & validation, FMEA, etc.
• System level root cause investigation; CAD/SolidWorks proficiency; tolerance analysis; capability analysis.
• Coordinate and implement design improvements with development partners.
• Collaborate with scientists and engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
• Accountability of maintaining technical records within product design history files.
• Individual contributor with leadership attributes to effectively represent device engineering within a large network/matrix organization.
• Working proficiency and familiarity with governing standards and regulations, including Quality System Regulation (21CFR820) and Risk Management (ISO 14971).

• Degree in the field of Mechanical or Biomedical Engineering, or related field
• Medical device industry and/or regulated work environment experience
• Excellent written and verbal communication skill
• Understanding and experience in:
• Development/commercialization of medical devices and knowledge of manufacturing processes
• Initiating and bringing complex projects to conclusion
• Ability to work independently and dynamic cross functional teams
• Design controls
• Failure investigation
• Applied statistics

• No laboratory experience or desire to work in a lab environment (not considering less than a year)
• No desire to work in cross-functional team environment
• Poor communication and technical writing skills
• Many positions in a short time frame (e.g. 3 per year)
• Interested in remote-only; this job requires on-site attendance