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:
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.
Required Qualifications:
Bachelor's degree or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills
Preferred Qualifications:
