A high-performing individual that will design and develop
medical devices from concept through market introduction on a
contract basis for client companies. The desired individual will
possess a broad range of medical device design and development
skills and experience, as well as depth of knowledge in several
clinical, product and technical areas. The ideal candidate is a
self-motivated individual who is excited by the prospect of working
in a dynamic, entrepreneurial environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Design and develop medical instruments (disposable and
reusable), catheters, implants, and/or packaging, from concept
through market introduction. Ensure that designs meet performance
specifications, regulatory and manufacturing requirements.
Generate innovative concepts for new medical device designs to
satisfy clinical requirements. Lead and participate in concept
generation activities, including brainstorming sessions. Refine,
rate, rank and/or otherwise assess concepts.
Manage product development projects. Prepare project plans that
specify project phases, tasks, task interdependencies, durations,
resource assignments, and costs. Proactively communicate task
assignments to responsible individuals, and ensure that tasks are
completed within the planned time. Track projects to project plans.
Proactively report project status to personnel and to the projects
Utilize SolidWorks to develop detailed 3-D CAD models and
drawings of medical instruments (disposable and reusable),
catheters, implants, and/or packaging. Includes component,
subassembly, and top-level drawings.
Interact with client companies in a professional manner.
Proactively communicate with client companies to ensure an ongoing
two-way exchange of information.
Generate project timing and expense estimates and prepare
project proposals for client companies.
Maintain Design History Files (DHFs) per company procedure.
Ensure that DHFs are accurate, complete and well organized.
Conduct risk analysis for products under development. Conduct
and document Failure Mode and Effects Analysis per company
Perform tolerance analysis of components and assemblies to
ensure proper fit and function.
Produce prototype devices for testing, and for evaluation by
client companies. Work with internal and/or external resources to
produce prototype device components. Assemble and/or evaluate
Conduct product verification and validation testing to
demonstrate product safety and efficacy. Determine what testing is
required to satisfy product requirements, to investigate potential
failure modes, and to otherwise address the project design inputs.
Develop protocols, plan testing, and perform or monitor testing.
Utilize statistical methods as required to plan testing and to
analyze test results. Write test reports which draw conclusions
from the results.
Ensure that all work satisfies the requirements of the company's
Quality Manual, with particular emphasis on Design Control.
Conduct Design Reviews as specified in project plans, and in
accordance with company procedure.
Prepare documentation release packages, including detail
drawings, bills of material, and/or procedures. Approve Document
Change Orders (DCOs) and obtain approvals from others as
Participate in Material Review Board activities. Make decisions
regarding product and material discrepancies and initiate
appropriate action to prevent subsequent problems or
Date, sign and have witnessed all documents that may establish
Significant local travel (i.e. by car). Approximately 10-20%
long-distance travel (i.e. by plane).
Any other duties as assigned.
May supervise other engineers.
REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE:
Bachelor's degree in Mechanical or Biomedical Engineering is
required. Masters degree in engineering, management or business is
Minimum of 5 years of medical device product design and
development experience is required.
Demonstrated ability to bring products from concept to
SolidWorks 3D CAD proficiency.
Familiarity with FDA QSR and ISO 13485 medical device
Knowledge of probability and statistics.
Depth of knowledge in one or more clinical areas; interventional
cardiology is desired.
Depth of knowledge in one or more product areas; catheters is
Depth of knowledge in one or more technical areas, for example
finite element analysis.
Flexibility, persistence, resourcefulness, a drive to succeed,
and an entrepreneurial spirit.