Overview
On Site
BASED ON EXPERIENCE
Contract - W2
Contract - Independent
Contract - 5+ mo(s)
Skills
DESIGN
MINITAB
ABBOTT
MEDTRONIC
GE HEALTHCARE
BECTON DICKINSON
STRYKER
BAXTER
JOHNSON and JOHNSON
BOSTON SCIENTIFIC
AVANDOS MEDICAL
SIEMENS HEALTHCARE
3M
CMR SURGICAL
DANAHER
INTUITIVE SURGICAL
FRESENIUS
ZIMMER BIOMET
EDWARDS LIFESCIENCES
ALCON LABORATORIES
ABLE MEDICAL DEVICES
MEDICAL DEVICE
MEDICAL DEVICES
MEDICAL DEVICES COMPANY
HEALTH SYSTEM
ISO 13485
ARTHREX
TE CONNECTIVITY
IEC 14708
45502
60601
GAUGE
DHF
DESIGN HISTORY FILE
DV
DESIGN VERIFICATION
Job Details
R&D Engineer III
Qualifications:
Preferred:
If this job is a match for your background, we would be honoured to receive your application!
Job Summary: Talent Software Services is in search of an R&D Engineer for a contract position in Marlborough, MA. The opportunity will be six months with a strong chance for a long-term extension.
Position Summary:
The Urology Research & Development (R&D) organization is seeking a highly skilled and motivated Mechanical Engineer to join our acquisition and integration project for a duration of six months, with the possibility to extend. In this role, you will provide support in integrating the acquired company's Design History File to the client's compliance. This role would be responsible for assessing the acquired company's design verification, test methods, and design outputs to determine if additional testing is required and either running the appropriate tests or updating associated documentation to rationalize why no testing is required. As a key team member, you will provide testing solutions and technical support under some guidance from our subject matter experts. You will utilize your background in mechanical and/or systems design, test method design and validation, verification testing and statistical analysis.Primary Responsibilities/Accountabilities:
- Identifying gaps in the acquired company's DHF compliance to *** Work Instructions and SOPs and contributing to the strategy to close these gaps.
- Providing input to project goals and progress and recommending appropriate revisions.
- Communicating progress, risks, and trade-offs of technical deliverables to project leadership and recommending revisions as needed.
- Completing complex or Client assignments requiring the development of new or improved techniques and procedures. Work is expected to result in efficient and effective integration of medical device technologies to the *** portfolio.
- Successfully completing engineering work in one or more of the following: Design FMEA; Design Verification test method; test method validation; DV protocol, testing, and report; Essential Design Output identification; and requirements tracing,
- Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
- Completing clear and concise engineering documentation, including protocols, reports, and rationales.
- Demonstrating Technology Development and Product Development system knowledge through the delivery of high-quality, high-impact deliverables.
Qualifications:
- BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
- 4+ yrs of engineering or related experience with a bachelor's degree, or 2+ yrs with a Master's
- Strong mechanical and/or systems engineering and problem-solving skills and attention to detail
- Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
- Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills
- Personal drive, individual accountability & a strong bias for action.
- 10% travel is possible
Preferred:
- Medical Device experience
- Familiarity with IEC 14708 and 45502 Active Implantable standards
- Familiarity with IEC 60601 Medical Electrical Equipment standards, including laser-specific sections
- Experience with statistical techniques (Gauge R&R, Process Capabilities Studies) and Minitab
- Experience in single-use device or active implantable test methods and test method validation
- Ability to build strong relationships across the organization and with external stakeholders
If this job is a match for your background, we would be honoured to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.