Principal Engineer, Post Market Surveillance

Johnson & Johnson Innovative Medicine•Danvers, MA

2d•$102,000 - $177,100•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for a Principal Engineer, Post Market Surveillance to be based in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose: This role reports directly to the Manager, Post Market Surveillance and engages in all activities related to the Abiomed post market surveillance processes. This role will enable signal detection, analyze complaint data trending, escalate trends or issues, and help create annual reports as needed in accordance with procedural guidance. This individual will present post market data in any forums as necessary (data review board, complaint trending meetings, etc.). This role will also provide support during inspections by regulatory bodies and ensure appropriate post market surveillance information is available and fit for delivery to the front room.

Requirements

Minimum BS degree with 6–8 years’ of relevant professional experience required.
Minimum of 3 years’ direct post market surveillance experience specifically performing complaint trending activities (strongly preferred).
Experience with fulfilling requests from internal and external audits preferred.
Demonstrated expertise in statistical methods and dataset analysis preferred.
Demonstrated experience mentoring or managing team members and leading complaint trending efforts preferred.
Ability to travel 10% domestically and internationally preferred.
Project management knowledge and understanding preferred.
Strong knowledge and experience in quality management of medical devices to maintain compliance with 21 CFR 820, 21 CFR 806, ISO 13485 & 14971, EU MDR preferred.
Demonstrated ability to create accurate and informative post market surveillance documentation consistent with applicable quality standards preferred.
Must be able to work independently, and demonstrate a high level of reliability, integrity, and personal accountability preferred.
Must have excellent written and verbal communication skills and have a strong working knowledge of the development, application, and measurement of quality performance metrics preferred.
Must be able to work U.S. Eastern Time (EST) hours.

Responsibilities

Subject matter expert accountable for Abiomed Post Market Surveillance (PMS) activities including leading discussions and presenting PMS data in any required forums.
Provide oversight of PQSS (monthly complaint trending) activities, including: Leading the complaint trending program and ensuring timely, accurate trending analyses. Mentoring, coaching, and managing team members involved in complaint trending activities. Assigning and reviewing trending work, ensuring deliverables meet quality expectations and procedural guidance. Facilitating training and development related to complaint trending methods and tools. Escalating trends or issues to management and cross-functional partners as appropriate.
Creates and presents post market surveillance data for management review.
Participates in cross-functional and global teams to execute post market surveillance activities.
Collaborates with cross-functional partners to investigate relationships between key risk factors, medication, and procedural information and adverse events/complaint rates.
Collaborates with cross-functional partners to create informative annual reports and other post market surveillance activities when such activities are required as part of the post market surveillance commitments.
Keeps abreast of current trends in literature and research pertaining to data analysis for complaints / adverse event data.
Ensures compliance with QSR, MDV, MDR, MPR, and any applicable country regulations and requirements regarding post market surveillance trending.
Supports additional information requests from global regulatory agencies.
Provides support during regulatory inspections and ensures PMS information is inspection-ready.
Working knowledge of FDA Medical Device Regulations including Quality System Regulation 21 CFR Part 820, and applicable international quality standards including ISO 13485:2013, Canadian MDR, EU MDR and country specific vigilance related regulations.
Strong analytical skills including trend and statistical analysis, interpersonal, and management skills.
Perform other duties as required.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits