Position:Senior Engineer
Location:Greater Boston, MA (Onsite)
Length:12 months
*W2CandidatesOnly,NoC2C
Job Description:
Our client is seeking a Senior Engineer to join their growing team. This role focuses on product development and reliability improvements for diagnostic systems within a regulated environment. The ideal candidate will apply engineering expertise to drive design changes, lead root cause investigations, manage risk assessments, and ensure timely delivery of project milestones. This is a hands-on, technically focused role requiring experience in medical devices, diagnostics, or similarly regulated industries.
Essential Duties and Responsibilities (but not limited to):
- Serve as an individual contributor or technical lead on designated projects.
- Perform design modifications and implement improvements focused on product reliability.
- Analyze complaint trends and conduct root cause investigations.
- Assess and mitigate design change risks as part of ongoing product improvements.
- Ensure the timely completion of assigned project deliverables in accordance with schedules.
- Generate and manage design control documentation in compliance with regulatory standards.
- Identify and document product defects and anomalies; evaluate their impact.
- Analyze technical data to identify trends and define subsequent actions.
- Provide technical input and support for investigations related to both development and on-market products.
- Communicate complex technical information effectively through written reports, presentations, and team discussions.
- Develop and maintain predictable timelines for engineering activities and deliverables.
Qualifications:
- Bachelor's degree in Engineering, Science, or a related technical field.
- 8-10 years of relevant experience in product development or engineering, or 5-6 years with an advanced degree.
- Experience in In-Vitro Diagnostics (IVD) or medical devices is highly preferred.
- Background in other regulated industries (i.e., aerospace, pharma, automotive) may also be considered.
- Strong understanding of design controls and regulatory compliance in a highly regulated environment.
- Demonstrated ability to lead technical projects and contribute to cross-functional teams.
- Analytical thinker with strong problem-solving skills and attention to detail.
- Clear and effective communication skills, both written and verbal.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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Digital Prospectors
May 30, 2025