Senior Mechanical Engineer (19-00236) – MA – Newton

Summary:
Lumicell is seeking a highly-motivated Senior Mechanical Engineer to work in a dynamic, fast-paced start-up environment. This is an exciting opportunity to join a company that has received excellent press and generated promising clinical data while still in its early development. The successful candidate must have a proven track-record in mechanical design and development for medical devices. Special consideration will be given to candidates with a history of working with optical engineers. The successful candidate is a self-initiating and independent problem solver who integrates well into existing company processes.
The Senior Mechanical Engineer will be responsible for supporting the development of Lumicell’s pipeline products, sustaining products in the field and helping to translate user requirements into design specifications. Special preference will be given to candidates with a history of successful transfer to manufacture and design for manufacture.
Responsibilities

  • Apply a functional knowledge of mechanical engineering principles, materials, structural mechanics and design for manufacturability and reliability towards achieving user requirements and design specifications
  • Support transfer to manufacturing process for pre-production prototypes
  • Perform design trade-offs for functionality, usability, cost and risk with input from key stakeholders both inside and outside of the company
  • Provide ongoing support for pipeline products and commercial systems
  • Assist with testing and validation of designs in accordance FDA guidelines.
  • Author documentation to support device design and risk management activities and preside over version control.
  • Provide prototyping support for early stage development work on a project basis.
  • Leading and conducting technical investigations, identifying root cause, conducting investigational test protocols, implementing corrective actions, and developing investigation report.
  • Work with cross-functional teams to identify gaps in product offerings
  • Manages mechanical projects through design, fabrication, evaluation, and documentation/reporting phases
  • Develops tests and methods, writes and performs test protocols, writes reports, and generates intellectual property

Qualifications

  • Masters in Mechanical Engineering or closely related engineering discipline
  • The ideal candidate will have 5-10 years of experience in the medical device field
  • Proven track record in design for manufacture and transfer to manufacture, with strong knowledge of manufacturing techniques, mechanisms, materials, and tolerancing
  • Experience with medical device design controls
  • Familiarity with 21 CFR 820, ISO 13485, IEC 60601 and IEC 62304 is also highly desired.
  • Proficiency and Efficiency with 3D modelling software
  • Experience with medical imaging, fluorescence imaging and/or optoelectronics is highly desired.

Source: Job Diva – Job Listing

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