Staff Mechanical Engineer

This role will lead and contribute to the creation and development of complex electro-mechanical systems by applying technical rigor for the innovation, creation and development of R&D and development programs to address the current and future needs of medical device products that improve the safe delivery of therapeutic drugs.

Responsibilities:

• Assume the role as SME (Subject Matter Expert) for an electro-mechanical system or subassembly.
• Lead the application of rigorous component, subsystem and system evaluation using first principles thinking and engineering analysis tools such as FEA and tolerance simulations.
• Manage internal and external stakeholders related to project activities.
• Oversee the development of production and process documentation, prepare technical analysis, and recommend strategic work related to new or improved products and processes.
• Provide technical skill and engineering support for design and development activities for new and existing products.
• Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance.
• Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies.
• Translate customer needs into engineering requirements for detailed product, packaging, and process specifications.
• Lead development and execution of test methods which specify measurement equipment, test set-up, measurement system analysis, data analysis.
• Create, develop, and release engineering drawings into a controlled documentation system.
• Document and write detailed technical reports based on design verification analysis/testing for all engineering activities.
• Ensure compliance to embecta quality policies, procedures, and practices as well as with all local, state, federal and embecta safety regulations, policies, and procedures.
• Any other tasks as assigned by your manager.
• May require up to 15% travel.

Knowledge, Skills and Abilities:

• Must be an SME in electro-mechanical systems and subsystems.
• Must be proficient in SolidWorks or other CAD packages.
• Must be proficient in GD&T.
• Must be proficient in running equipment such as Instron testers, leak testers or syringe pumps.
• Must have a thorough understanding of product development for tightly controlled and high-volume manufacturing processes; Product and process validation including V&V, TMV, FAI and FAT/SAT IQ/OQ/PQ.
• Must have a thorough understanding of data acquisition, analysis and statistical techniques using Labview, Matlab or Minitab.
• Must be able to work cross-functionally with Systems, Quality, Manufacturing, Molding and Hardware engineering groups.
• Must be able to work independently with limited direction.
• Must be able to balance multiple projects and activities.

Basic Qualifications:

• BS degree in engineering is required (Mechanical or Biomedical preferred).
• 5 years of engineering experience is required, preferably in medical devices.

Preferred Qualifications:

• MS preferred.