REQ Solutions
4 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
This range is provided by REQ Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $55.00/hr - $70.00/hr
Job Title Mechanical Engineer (Medical Device)
Hybrid Role Hybrid Role
Responsibilities
The Urology Research & Development (R&D) organization is seeking a highly skilled and motivated Mechanical Engineer.
Provide support in integrating the acquired company’s Design History File to client's compliance
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.
Utilize your background in mechanical and/or systems design, test method design and validation, verification testing and statistical analysis.
Identifying gaps in the acquired company’s DHF compliance to Work Instructions and SOPs and contributing to strategy to close these gaps.
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 delivery of high quality, high impact deliverables.
Education/Experience
BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
4+ yrs of engineering or related experience with bachelor’s degree, or 2+ yrs with 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
10% travel is possible.
Education/Experience
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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at REQ Solutions by 2x
#J-18808-Ljbffr
Get AI-powered advice on this job and more exclusive features.
This range is provided by REQ Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $55.00/hr - $70.00/hr
Job Title Mechanical Engineer (Medical Device)
Hybrid Role Hybrid Role
Responsibilities
The Urology Research & Development (R&D) organization is seeking a highly skilled and motivated Mechanical Engineer.
Provide support in integrating the acquired company’s Design History File to client's compliance
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.
Utilize your background in mechanical and/or systems design, test method design and validation, verification testing and statistical analysis.
Identifying gaps in the acquired company’s DHF compliance to Work Instructions and SOPs and contributing to strategy to close these gaps.
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 delivery of high quality, high impact deliverables.
Education/Experience
BS or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
4+ yrs of engineering or related experience with bachelor’s degree, or 2+ yrs with 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
10% travel is possible.
Education/Experience
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.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Medical Equipment Manufacturing
Referrals increase your chances of interviewing at REQ Solutions by 2x
#J-18808-Ljbffr