Location: Danvers, MA
Company: Johnson And Johnson
verification test plan and protocols. KEY RESPONSIBILITIES Understand device design and core technologies in order to inform test method development Review, update, understand and determining the scope of testing required Develop test methodologies within framework of SOP's and FDA guidelines Create verification and validation test plans Write concise and effective test protocols Informal and formal test execution of verification and validation protocols Produce test reports, document test results, maintain records and assure traceability Creating and evaluating test fixtures needed for product design verification Contributing to design failure investigations that may impact Risk backssment,
Hazard Analysis, and FTA's QUALIFICATIONS BS or MS in Electrical Engineering, Mechanical, Software Engineering, Biomedical Engineering or related field required Minimum of 2 years of Verification & Validation experience Medical Device Experience Fundamental understanding of 60601-1 standards May require up to 5% travel - US & EU Preferred: Prior experience in embedded device testing Fundamental understanding of design controls Familiarity with JAMA requirements management software Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual
orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers..
Engineering jobs encompass a vast array of specialized roles within the field of engineering, aimed at designing, developing, and maintaining various technological systems and structures. These roles typically require a strong foundation in mathematics and science, and they span across numerous sectors such as civil, mechanical, electrical, and software engineering, among others. The key features of engineering careers include problem-solving, innovation, and the application of practical knowledge to create solutions that can improve people's lives, enhance business operations, or even address global challenges. Engineers often work in teams, collaborate with other professionals, and are at the forefront of technological advancement.
Engineering jobs encompass a variety of roles that involve applying scientific and mathematical principles to solve real-world problems. These positions are typically associated with the design, development, and maintenance of structures, machines, and systems. Engineers are known for their technical expertise, problem-solving skills, and the ability to innovate. Characterized by fields such as civil, mechanical, electrical, chemical, and software engineering, these jobs often require specialized education and can lead to careers in industries like construction, manufacturing, technology, and environmental management. Engineering professionals play a vital role in shaping the future through sustainable and efficient design.
robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. I Am Abiomed I Am Heart Recovery Patients First!
The Sr. Electrical Engineer in the Post Market Engineering group plays an integral role in Abiomed's Quality Department, conducting post-market investigations of FDA-approved medical devices. In this position, you will conduct complaint failure investigations and lead CAPAs. This is a position designed to build upon engineering skillset that includes root cause analysis, fixture design, project management, medical
device knowledge, and cardiology clinical background. Principle Duties and Responsibilities: • Function as the lead complaint investigator. Investigate complaints by reviewing clinical notes, analyzing medical device data, and by troubleshooting returned products to determine a root cause • Serve as a subject matter expert for durable products and their associated failure modes • Identify optimal analytical approaches critical to problems by mitigating/ resolving failures to improve product quality and reliability • Develop root cause failure analysis techniques to automate processes and testing methods • Apply statistical tools to analyze data and drive problem resolution • Drive corrective
and preventive actions in a timely manner to prevent the re-occurrence of problems • Lead engineering projects through design changes (HW/SW), which includes modifying schematics, PCB layouts, and other engineering models • Run small projects by developing a project plan and adhering to design controls• BS in Electrical Engineering, Biomedical Engineering, or directly related scientific discipline required.
MS desired • Minimum of 4 years of related work experience • Experience interpreting circuit schematics, BOMs, and technical drawings • Knowledge of electrical design software tools (Schematic capture and PCB layout) • Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) • Determination to overcome obstacles and the initiative to execute tasks in a timely manner without direct supervision • A passion for medical devices and making a significant positive impact on the lives of our patients • May require up to 10% travel - US & EU Preferred Qualifications • Project lead experience is a plus • Medical device and electromechanical design experience preferred • Ability to troubleshoot electronics down to component-level • Experience with programming languages such as C/C , Python, Matlab, and SQL • Knowledge of electronics manufacturing and ability to interface with suppliers • Experience with fiberoptics and digital communication protocols • Cross-functional experience with hardware/ software and analog/ digital systems Abiomed is an Equal Opportunity Employer committed to a diverse workforce.
Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, interactionual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
Abiomed maintains a drug-free workplace.
respiratory support, with a mission of recovering hearts & saving lives. Abiomed's " Patients First! " culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.
Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation. This role reports directly to the Director, Post Market Surveillance and engages in all activities related to the Abiomed post market surveillance processes. This role will help manage annual reports, track and trend complaint data, enable
signal detection, and escalate trends or issues 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. Responsibilities : • Subject matter expert accountable for Abiomed Post Market Surveillance (PMS) activities including leading discussions and presenting PMS data in any required forums. • Develops and presents post market surveillance data for management review. • Participates
in cross-functional and global teams developing and managing post market surveillance activities.
• Collaborates with key business partners to develop and implement effective data analysis associated with post-launch monitoring of product performance in the field. Explores and investigates relationships between key risk factors, medication, and procedural information and adverse events/complaint rates. • Collaborates with business partners to develop 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. • Support additional information requests from global regulatory agencies. • 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. Education: • BS degree with at least 5 years' experience in medical devices specifically related to post market surveillance Requirements: • Experience with FDA audits in both a front and backroom capacity is preferred • Statistical knowledge and understanding • Ability to travel 10% domestically and internationally • Demonstrated successful project management preferred • Strong leadership skills to inspire high quality, timely work, and instill a spirit of continuous improvement • 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 • Demonstrated ability to implement and maintain accurate documentation consistent with applicable quality standards • Must be able to work independently, and demonstrate a high level of reliability, integrity, and personal accountability • Must have excellent written and verbal communication skills and have a strong working knowledge of the development, application, and measurement of quality performance metrics For U.
S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $125,000 to $165,000.
Additional information can be found through the link below. For additional general information on company benefits, please go to: www. careers. /employee-benefits Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
