Senior Mechanical Engineer

1 hour ago

Raleigh, North Carolina, United States Komak Consulting Services Full time

FULLY ONSITE in Raleigh, NC

Will not accept candidates that require sponsorship

3 days in office, averaging 20 hrs/week.

The schedule would be flexible. We don't anticipate a full workload, but when the temp works is at their discretion. So, if they want to come in 5 days a week for 4 hours, or if they want to come in only 3 days, both are acceptable.

Description

Principal mechanical engineers develop new products, redesign existing products, and perform research

and testing on product concepts related to medical devices. This individual will be an important member

of the Merz Advanced Development team focused on research, development, and bringing to market

medical devices to support Merz business objectives. The successful candidate will be involved with

projects covering all aspects of advanced development including concept, design, verification testing and

transfer to manufacturing.

Must have worked in a medical device company and familiar with regulatory and quality requirements throughout all stages of the product development life cycle.

1.     Technical Lead

  • Technical leadership of system features and functions as applicable to a medical device. Expectation is this leadership requires collaboration and leading of other engineering groups.

2.     Mechanical Engineering

  • Take leadership of projects in development, managing all team members assigned to projects to keep them moving forward on schedule.
  • Provide engineering analysis, feasibility reports and studies to assist advanced development projects.
  • Provide broad mechanical engineering technical

expertise through various phases of product life cycle.

3.     Innovation

  • Develop, design, and test innovative concepts and solutions which align with the needs of the clinic, patient and business.
  • Collaborating with the engineering and marketing department on product feasibility.
  • Provide mechanical engineering subject matter expertise in designing and building test setups and fixtures for various Advanced Development projects.

4.     Documentation

  • Maintain accurate documentation throughout the design process per GDP and GMP.
  • Write product requirements and specifications to support feature.
  • Plan, design, execute and report on system experiments as related to feature development and the product roadmap.

5.     Test Methods

  • Prove product design by developing test plans, adjusting design, running performance calculations, maintaining quality standards and approve prototypes.
  • Validation of the test tool or setup is usually required.

6.     Prototype manufacturing

  • Lead engineering prototype builds, including generating BOMs, ordering parts and materials, and training lab technicians.
  • Work closely with pilot manufacturing line and operations group to develop a device build process.

7.     Good laboratory practice proficiency

  • Complete knowledge in operating critical lab equipment such as oscilloscope, microscope, acoustic tank, force balance, translation stage, impedance analyzer, pulseecho fixture, cryostats, and training others.
  • Experience testing PCBA and soldering parts.

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