Clinical Engineer

We are hiring a Clinical Engineer to work hybrid out of our Andover, MA office.

The Clinical Engineer plays a critical role in product development by contributing to the design, implementation, and validation of multi-parameter patient monitoring and system solutions. Serve as the clinical application expert that will work with end users to gain understanding of clinical needs, behavior, and workflow and translate to development teams. With oversight from more senior Clinical Engineers, support clinical evaluations, including alpha/beta testing, and clinical trials and usability activities. She/he will act as an advocate for the clinician and patient with a focus on delivering products that improve patient and hospital outcome.

Main Responsibilities:

• Support a cross-functional project team and execute clinical engineering activities according to the program plan and communicate key project risks/concerns to the clinical engineering lead.
• Contribute to the definition of design inputs as it pertains to user and performance needs/requirements and support implementation to ensure the most desired solutions are delivered that meets the needs of the patients and clinicians.
• Participate in product risk analysis to identify clinical risks, including use related hazards, that may result due to normal use, reasonably foreseeable misuse, or abnormal use in collaboration with the risk manager and other engineering disciplines in accordance with internal processes and standards (ISO 14971).
• Engage with clinical experts to gain understanding of clinical needs and product opportunities to translate to product development teams.
• Support product validation activities including writing test protocols, gathering clinical data, performing data analysis, identifying design improvement opportunities, and authoring summary reports with guidance from the clinical engineering lead.
• Ensure all clinical engineering deliverables and activities comply with clinical engineering best practices, processes, and tools.
• Support clinical trials and usability evaluation activities.
• Support clinical evaluation documentation reviews for EU MDD/MDR, including Clinical Evaluation Plans and Reports, post-market data, and PMCF Plans and Reports.
• Performs other duties as needed and assigned.

• BS in engineering (biomedical or related), biosciences and/or nursing required; Master's degree preferred
• 2-5 years' experience in the medical device industry, with relevant work experience in clinical/user research, product validation, and/or clinical studies
• Experience developing medical devices in regulated industry at all stages from concept through post-market release, patient monitoring experience preferred
• Experience as a nurse, or clinical/biomedical engineer in hospital environment is preferred
• Experience in product validation including successful interaction with the FDA and other regulatory bodies through product approval

Compensation

The targeted pay range for this position is typically between $80,000-$85,000. We note that the base pay offered is based on market location and may vary further depending on individualized factors for job candidates, such as job-related knowledge, skills, experience, and other objective business considerations. This position is eligible for an annual bonus.