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Product Development Engineer in Lexington, MA at APEX Systems

Date Posted: 4/15/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Lexington, MA
  • Job Type:
  • Experience:
    Up to 8 year(s)
  • Date Posted:
    4/15/2019

Job Description

Job #:  928930

Product Development Engineer – Medical Device


An innovator in next generation of absorbable biomaterials is seeking an ambitious, engineering professional interested in helping to change the lives of many patients around the world.  The Product Development Engineer will provide solutions to a variety of technical issues related to device applications in orthopedic, general, and plastic surgeries. The expertise required for this role includes both product and process developments in support of the existing commercial products as well as in the introduction of the new product lines.

 

Primary Responsibilities:

  • Provide technical expertise to the design and development of new and existing invasive medical device product(s)
  • Interfaces with physician KOL’s and Marketing to assess market opportunities, develop user needs and provide cost and timeline estimates
  • Develop new products from initial design concept to market release applying the stage gate approach to Design Controls
  • Conduct product development to meet the expectations of international standard, ISO 13485, Quality Systems – Medical Devices – System Requirements for Regulatory Purposes and the FDA 21 CFR 820, Quality System Regulation.
  • Lead or assist with Risk Management as per ISO 14971
  • Lead or assist in the product verification and process validation activities (IQ/OQ/PQ)
  • Conducts experiments and analyze different materials, manufacturing processes, design tolerances and other factors in the developmental process
  • Provide hands-on design, generate SolidWorks drawings, fabricate prototypes, bench top testing and interface with various vendors to manufacture finished devices
  • ?Co-ordinate bio-skills/cadaver labs to evaluate prototypes, gain product feedback, train end users, and validate new designs
  • Conduct pre-clinical animal studies in support of new product developments
  • Validate, scale up and transfer to Manufacturing turn-key operation
  • Create effective CAPA’s for compliance actions
  • Research, analyze and create intellectual property

 

Job Qualifications:

 

  Education:

  • Bachelor’s Degree in Mechanical, Biomaterials, Biomedical Engineering or equivalent from an accredited institution required; Master’s Degree preferred.

 

Desired Experience and Skills:

  • Minimum of 5-8 years of mechanical medical device development experience, including implant and instrumentation in the field of orthopedics, general surgery or plastics
  • Plastics / textile processing experience - injection molding, extruding, bonding, knitting, braiding or other related processing methods is a strong plus
  • Knowledge of FDA GMPs, ISO 13485:2003, ISO 14971
  • Knowledge in the application of design controls
  • Knowledge of process validation IQ/OQ/PQ
  • Have flourished working within a defined product development process, FMEAs, Design Reviews, DHF, etc.
  • Experience in designing complex medical device products on time (concept to launch)
  • Have a good understanding and working knowledge of manufacturing processes, materials, and quality assurance protocols
  • Experience using statistical tools to improve quality
  • Self-starter, analytical, detailed oriented, and tenacious problem solver
  • Strong communication and organization skills to drive awareness and execution in a small, fast-moving, and nimble organization
  • Experience working with surgeon and healthcare professional
  • Ability to prioritize and manage several projects simultaneously ? 
  • Working knowledge/expertise in SolidWorks

 

 

 

 

 

 

 

 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178