What are the responsibilities and job description for the R&D Engineer I position at Medical Engineering Consultants (MEC)?
Job 2645 - Associate R&D Engineer - Contract located in Marlborough, Massachusetts
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Hybrid 3 days
About The Role
Join our client's Urology in the fast-paced world of acquisitions and integrations!
The Urology Research Development R&D organization is seeking a highly skilled and motivated R&D Engineer to join our team.
In this role you will provide support to assess design effectiveness of medical devices and evaluate compliance with our client's requirements and international standards as part of an acquisition and integration of a third-party company.
This role would be responsible for assessing the acquired company's Design History File DHF and updating associated design documentation and design outputs to address any gaps against the client's Quality Management System.
As a key team member, you will provide design solutions and technical support under some guidance of 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.
Your Responsibilities Include
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Hybrid 3 days
About The Role
Join our client's Urology in the fast-paced world of acquisitions and integrations!
The Urology Research Development R&D organization is seeking a highly skilled and motivated R&D Engineer to join our team.
In this role you will provide support to assess design effectiveness of medical devices and evaluate compliance with our client's requirements and international standards as part of an acquisition and integration of a third-party company.
This role would be responsible for assessing the acquired company's Design History File DHF and updating associated design documentation and design outputs to address any gaps against the client's Quality Management System.
As a key team member, you will provide design solutions and technical support under some guidance of 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.
Your Responsibilities Include
- Testing products for feasibility test method development and formal design verification testing
- Providing input to project goals and progress and recommending appropriate revisions.
- Communicating progress risks and trade-offs of technical deliverables to project leadership and recommends revisions as needed.
- Successfully completing engineering work in one or more of the following: technology development or remediation product design refinement test of materials preparation of specifications process study and report preparation.
- Assessing the feasibility and soundness of alternative engineering processes products or equipment.
- Completing clear and concise engineering documentation.
- Demonstrating Technology Development and Product Development system knowledge through delivery of high-quality high impact deliverables.
- Bachelor's degree or above in Mechanical Engineering Biomedical Engineering Electromechanical Engineering or related field
- 1 year of engineering or related experience with bachelor's degree
- Experience with formal testing and data logging of medical device/products
- Experience with Instron or equivalent test equipment
- Experience with mechanical testing
- Experience working on Medical Device DHF
- 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
- Experience with integrations and working with cross cultural teams
- Test Method development and validation experience
- Experience in Minitab
- Experience in single-use device or medical electrical equipment System Design Verification testing and data analysis
- Ability to build strong relationships across the organization and with external stakeholders
- Familiarity with ISO 60601
- Sponsorship is not available for this position
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.