Apply for JobClinical EngineerApply for Job at Draeger

North Andover, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

85000.0

Posted On

15 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Engineering, Product Development, User Research, Clinical Trials, Usability Testing, Risk Analysis, Data Analysis, Regulatory Compliance, Patient Monitoring, Design Inputs, Clinical Evaluation, Medical Devices, Collaboration, Test Protocols, Clinical Needs Assessment, Product Validation

Industry

Manufacturing

Description

Clinical Engineer Business Unit: Draeger Medical Systems, Inc., Job-ID: 1045 Location: Andover Function: R&D Work Location: Hybrid Employment Type: Permanent The Job Responsibilities 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. Your Qualifications 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. Dräger Benefits At Draeger, Technology for Life means supporting our people in every aspect of their lives. We offer a competitive benefits package that may include: Medical, dental, and vision insurance Life, short- and long-term disability coverage 401(k) with company match Over 4 weeks of paid time off, plus holidays and parental leave Flexible spending accounts and employee assistance program Select locations also offer free parking, an on-site gym, cafeteria, and game room. Talk to your Draeger recruiter to learn more! Who we are We’re hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle “Technology for Life”. Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario. Draeger is an Equal Opportunity Employer. Interested? Please, apply directly through our career portal.We look forward to receiving your application.

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Responsibilities

The Clinical Engineer will support cross-functional project teams and execute clinical engineering activities, ensuring compliance with best practices. They will also engage with clinical experts to understand needs and support product validation activities.