Overview:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Our F500 Medical Device client has an exciting opportunity for an R&D Engineer.

Job Summary:

We are 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 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 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.

This role follows a hybrid work model, requiring employees to be in our local office (Marlborough, MA) at least three days per week.

Responsibilities:

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.

Required Qualifications:

Bachelor's degree or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field

1+ yrs 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

Preferred Qualifications:

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

Pharmavise Corporation

Latest Jobs

R&D Engineer I — Medical Device (Hybrid – Marlborough, MA) Contract