Senior Mechanical Engineer

 

Position Title: Senior Mechanical Engineer

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: Senior Director, Research and Innovation

 

 

Summary

 

We are 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.

 

 

Essential Duties and 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

 

Education and Required Experience:

  • 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

 

Critical Competencies for Success

  • Excellent problem-solving, troubleshooting, and communication skills
  • Detail oriented and highly organized
  • Must be able to work independently and as part of a team, learn quickly, and take on responsibilities outside of this scope of work, as necessary
  • Must have strong patient and user focus and design with patient outcomes in mind
  • Must be resilient and focused with a knack for navigating complex and occasionally ambiguous environment

 

Supervisory Responsibility

  • This position has no supervisory responsibilities

 

Work Environment

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers, photocopiers and smartphones

 

Position Type/Expected Hours of Work

  • This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours.  Occasional evening and weekend work may be required as job duties demand

 

Travel

  • Some travel may be expected for this position including internal meetings, conference and or training events

 

EEO Statement

  • Lumicell is an equal opportunity employer

 

Other Duties

  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice

To apply for this position, please send your resume to careers@lumicell.com.