Manager of Clinical Engineering

Lawrence, MA

Job Type: Direct Hire | Recruiter: Dana Tarlow | Phone: 781.696.5733

Find your job at www.LoveYourJob.com

Job Title: Manager of Clinical Engineering

Location: Lawrence, MA

Duration: Direct Hire

POST-OFFER BACKGROUND CHECK IS REQUIRED. An essential function of this job is physical attendance. 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, or veteran status.

JOB DESCRIPTION:

We're seeking a Manager of Clinical Engineering who will be providing leadership and support in daily activities, developing strategy and implementing program initiatives, processes, and practices for the Clinical Engineering team for both current and next-gen monitoring products and system platforms. Applying strong understanding of both product development and how products are utilized in a hospital environment, the Manager is passionate about the organization's building products and systems that meet customer and regulatory requirements. You will be creating an inspirational team environment with an open, collaborative culture.

1 Developing strategic initiatives and plans for the Clinical Engineering organization, achieving business objectives while coaching and directing the team on implementations and driving these initiatives.

2 Providing guidance and mentorship to the clinical engineering team on critical internal processes such as design/ development and product validating, supporting the daily activities, motivating team members, and keeping upper management in the loop on team performance, risks and problems.

3 Hiring and developing employees, demonstrating leadership and ability to manage others.

4 Effectively estimating and managing timelines of multiple product lines, collavorating with the program leads, and optimizing efficiencies and Clinical Engineering resources while able to shift priorities as business needs dictate.

5 Actively participating in leadership team activities and meetings. Serving as primary correspondent to other clinical organization counterparts within the organization, advocating for and making visible the efforts that can benefit the different business units.

6 Building and maintaining contacts with clinical experts and key opinion leaders, expanding clinical partnerships, and staying current with clinical needs and workflow, medical innovation, regulations, and technology.

7 Ensures company and department compliance with all internal processes and relevant US, EU and other industry regulations. Serving as local process owner of several internal processes, developing and improve processes, protocols, and providing training to the team.

8 Interfacing regularly with both internal and external stakeholders, ensuring product development programs have met customer and regulatory needs, and discussing clinical engineering organizational status, metrics, risks and to address issues/concerns.

9 Performing other duties as needed and assigned. 

 

Qualifications:

Education: BS in engineering (biomedical or similar field) required; Master’s degree is desired.

· Ten or more years of experience in the med device industry, with relevant work experience to include clinical research/engineering, product validation, & clinical studies

· A background working in a hospital environment, either as nurse or physician, and having engaged with end users and key opinion leaders (desired).

  • Two or more years of proven track record of building and leading teams

  • A background in the development of med devices throughout the stages of concept through post-market release- patient monitoring experience is desired

  • Experience with successfully completing multiple clinical studies or product validation to include successful interaction with the FDA and other regulatory bodies through product approval.

Special Competencies or Certifications:

  • Able to lead effectively in a diverse and collaborative culture with a wide range of functions and expertise levels.

  • Strong leadership, analytical, organizational, planning, delegation, and communication skills.

  • Strong understanding of product validation and relevant regulations and FDA guidance.

  • Familiar with relevant regulations for clinical trials such as ICH guidelines, GCP, FDA and applicable international regulations and practices.

  • Understands US and international regulations for medical device manufacturers, including EU/MDR as it pertains to clinical evaluation.

  • Demonstrating high proficiency in the following areas: driving organizational strategy, building networks & relationships, and attracting, developing & retaining top talent.

Work Environment / Conditions:

Able to work as a team player while 

Able to work in a fast-paced environment with varying amounts of individual responsibilities, able to resolve conflicts, redirect priorities, etc.

Able to travel both nationally and internationally, up to 10 or 20% of the time.

 

Make this your next career move as one of our many long-term contractors or employees!

Work as our full-time employee with full benefits (Medical, Dental, Vision, STD, LTD, PTO, Retirement, etc.)  - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.

ABOUT DIGITAL PROSPECTORS:

Founded in 1999, Digital Prospectors is an award-winning recruiting and consulting firm that specializes in placing contract, contract-to-hire and direct hire engineers into rewarding opportunities with our impressive and ever-growing client base. We believe that all people should love their jobs.

Come see why Digital Prospectors has been voted “Best Staffing Firm to Temp For” by Staffing Industry Analysts, "Best of Staffing" for candidate satisfaction by Inavero / CareerBuilder.com, "Top Temporary Placement Firm" by Boston Business Journal, "Best Company To Work For" by Business NH magazine, "Excellence in IT and Engineering Staffing” by TechServe Alliance, "Top IT Services Company" by Inc. Magazine, "Most Reliable Staffing Agency" in Forbes Magazine and "Top Ranked Staffing Firm" by Staffing Industry Analysts.

www.LoveYourJob.com

Phone: 603-772-2700

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