- Oversees and executes the Post-Market Surveillance (PMS) program
- Authors Post-Market Surveillance Plans, Post Market Surveillance Reports (PMSR), and Periodic Safety Update Reports (PSUR).
- Gathers, analyzes, and reports on PMS data within the defined PMS period to ensure compliance with defined frequency requirements.
- Identify, analyze, and interpret trends or patterns in complex data sets. Evaluate the information using sound statistical rationale and objective risk-based decision making
- Owns and leads collaboration with cross-functional PMS Team to define and agree upon recommended actions and/or documentation updates based upon PMS findings (to be reported within the PMSR/PSUR).
- Initiates Corrective Action Requests and other activities, such as design/process changes or Risk Management File updates, based on PMS findings.
- Participates in Management Review and communicates findings to Senior Leadership, including status of PMS activities and escalates quality issues as appropriate.
- Help ensure accurate PMS process procedures are maintained and compliant with applicable standards and regulations.
- Monitor external regulations, standards, guidance documents, and common specifications to identify compliance gaps and maintain compliant PMS processes.
- Provide guidance to product Subject Matter Experts (SMEs) in technical matters related to PMS.
- Identify development and training opportunities for the organization in relation to PMS activities and best practices.
- Participate in internal and 3rd party audits as Post-Market Surveillance SME
- Supports responding to requests for additional information related to PMSRs or PSURs from Competent Authorities, Registries, and Notified Bodies.
- Investigates and evaluates new failure modes when encountered.
- Provide expertise in risk management techniques when assessing post-market data, including complaints, adverse events, and user feedback.
- Contributes to the team effort by accomplishing related tasks as needed.
- Support other quality initiatives including, but not limited to, support of design control activities, maintenance of risk management files, and continuous improvement initiatives.
- Bachelors or Master's Degree in Engineering or other Scientific or Technical area.
- Minimum of three (3) years of experience with medical device post-market surveillance, design quality engineering, or similar.
- Strong computer skills, including MS Office applications (Word/Excel) are required.
- Strong project management, prioritization and leadership skills are required.
- Working knowledge of FDA Quality System Regulations (21 CFR Parts 820 & 822), European Medical Device Regulations (EU MDR; specifically Articles 83, 84, 85 & 86), Canadian Medical Device Regulations (CMDR), Therapeutic Goods Medical Device Regulations (TGA), ISO 13485, ISO 14971, BS EN , and other recognized international standards and how they relate to post-market surveillance, design control, risk management, and other quality practices.
- Excellent analytical, problem-solving, and applied thinking skills.
- Demonstrated ability to motivate multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Team player with ability to successfully interact with representatives from a variety of disciplines.
- Strong collaboration skills.
- Excellent verbal and written communication skills.
- Experience with statistics, including the ability to acquire, query, and analyze data and interpret results.
- High level of attention to detail and accuracy.
- Demonstrated ability to identify missing information and evaluate accuracy of presented information.
- Ability to prioritize and manage key deliverables in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
- Knowledge of Good Documentation Practices (GDP) required.
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- May work extended hours during peak business cycles.
- This position may require some travel to Getinge or partner sites (<5%).
- May work on-site and remotely, minimum requirement of 3+ days on-site.
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
-
Principal Design Quality Engineer
6 days ago
Elbit Systems of America Merrimack, United States PermanentJob Description · The Principle Design Quality Engineer will work as a member of a cross-functional project team engaged in new product development. The individual will serve as a quality representative on development projects and will work closely with Engineering, Manufacturing ...
-
Principal Design Quality Engineer
2 weeks ago
Digital Prospectors Merrimack, United StatesPosition: · Principal Design Quality Engineer · Location: · Merrimack, NH (Onsite) · Length: · Direct Hire · Job Description: · Our client is seeking a Principal Design Quality Engineer who will work as a member of a cross-functional project team engaged in new product develo ...
-
Engineer II, Design Quality
3 weeks ago
Getinge Merrimack, United StatesAt Getinge we have the passion to perform · Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering ...
-
Principal Design Quality Engineer
3 weeks ago
Digital Prospectors Merrimack, United StatesPosition: Principal Design Quality Engineer · Location: Merrimack, NH (Onsite) · Length: Direct Hire · Job Description: · Our client is seeking a Principal Design Quality Engineer who will work as a member of a cross-functional project team engaged in new product development. The ...
-
Principal Design Quality Engineer
3 weeks ago
Digital Prospectors Merrimack, United StatesPosition: Principal Design Quality Engineer · Location: Merrimack, NH (Onsite) · Length: Direct Hire · Job Description: · Our client is seeking a Principal Design Quality Engineer who will work as a member of a cross-functional project team engaged in new product development. ...
-
Principal Design Quality Engineer
2 weeks ago
Elbit Systems Merrimack, United StatesThe Principle Design Quality Engineer will work as a member of a cross-functional project team engaged in new product development. The individual will serve as a quality representative on development projects and will work closely with Engineering, M Quality Engineer, Engineer, D ...
-
Principal Design Quality Engineer
1 week ago
Elbit Systems of America Merrimack, United StatesJob Description · Job DescriptionCompany Description · KMC Systems, an Elbit Systems of America company, offers an ecosystem of engineering and innovation to develop the most advanced clinical and operational solutions for leading medical device customers across a diverse range o ...
-
Elbit Systems of America Merrimack, United StatesJob Description · The Principle Design Quality Engineer will work as a member of a cross-functional project team engaged in new product development. The individual will serve as a quality representative on development projects and will work closely with Engineering, Manufacturin ...
-
Design Quality Engineer
2 weeks ago
Mondo Westford, United StatesJob Description · Job DescriptionApply now: Design Quality Engineer, location in Westford, MA. The start date is ASAP for this long-term contract position. · Job Title: Design Quality Engineer · Location-Type: Westford, MA · Start Date Is: ASAP · Duration: Contract · Compensatio ...
-
Senior Design Quality Engineer
1 week ago
TransMedics Group, Inc. Andover, United StatesJOB DESCRIPTION · Position: Sr. Design Quality Engineer · Reports to: Senior Director, Quality Assurance · ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE: · * Responsible for the overall health of design control process. Responsible for assuring NPI and sustaining projects mee ...
-
Senior Design Quality Engineer
3 weeks ago
TransMedics Group, Inc. Andover, United StatesJOB DESCRIPTION · Position: Sr. Design Quality Engineer · Reports to: Senior Director, Quality Assurance · ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE: · * Responsible for the overall health of design control process. Responsible for assuring NPI and sustaining projects mee ...
-
Design Quality Engineer
1 week ago
Mondo Westford, United StatesApply now: Design Quality Engineer, location in Westford, MA. The start date is ASAP for this long-term contract position. · Job Title: Design Quality Engineer · Location-Type: Westford, MA · Start Date Is: ASAP · Duration: Contract · Compensation Range: $35-40 Per Hour W2 ...
-
Design Quality Engineer
1 week ago
Analog Devices Wilmington, United StatesAnalog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized facto ...
-
Design Quality Engineer
1 week ago
Mondo Westford, United StatesApply now: Design Quality Engineer, location in Westford, MA. The start date is ASAP for this long-term contract position.Job Title: Design Quality EngineerLocation-Type: Westford, MAStart Date Is: ASAPDuration: ContractCompensation Range: $35-40 Per Hour W2 The estimate above re ...
-
Design Quality Engineer
6 days ago
Analog Devices Wilmington, United StatesAnalog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized facto ...
-
Design Quality Engineer
1 week ago
Mondo Staffing Westford, United StatesApply now: Design Quality Engineer, location in Westford, MA. The start date is ASAP for this long-term contract position. Job Title: Design Quality Engineer Location-Type: Westford, MA Start Date Is: ASAP Duration: Contract Compensation Range: $35-40 Per Hour W2 The estimate abo ...
-
Principal Design Quality Engineer
3 weeks ago
Elbit Systems Manchester, United StatesPrincipal Design Quality Engineer - KMC REF1877K · Full-time · KMC Systems, an Elbit Systems of America company, offers an ecosystem of engineering and innovation to develop the most advanced clinical and operational solutions for leading medical device customers across a divers ...
-
Design Assurance Quality Engineer III
3 weeks ago
Omnicell Cranberry, United StatesJob Description · Quality Assurance Engineer III, Design Assurance · Reporting to the Director or Manager of Quality Design Assurance, the Quality Design Assurance Engineer will be responsible for leading Design Assurance activities in collaboration with cross-functional person ...
-
Sr. Engineer, Design Quality Assurance
1 week ago
Fresenius Medical Care North America Lawrence, United StatesPURPOSE AND SCOPE · Participate in the New Product Development (NPI) and design changes, Design History File (DHF) and Device Master Record (DMR) reviews meetings and fully understand the design control process and Quality Engineering. Utilize technical training and compliance e ...
-
Senior Design Quality Engineer
3 weeks ago
TransMedics, Inc. Andover, United StatesTransMedics, Inc., headquartered in Andover, MA, is revolutionizing organ care. With the goal of bringing new life to organ transplant, the pioneering Organ Care System (OCSTM) was developed to address the major limitations of the current standard of care, cold storage. The OCS S ...
Engineer II, Design Quality - Merrimack, United States - Getinge
Description
At Getinge we have the passion to perform
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives.
Are you looking for an inspiring career? You just found it.
HYBRID: Eligible to work from home 1 - 2 days/week.
Job Overview
This position will lead Getinge's Post-Market Surveillance (PMS) program for the Merrimack, NH site for an exciting and diverse portfolio of products. This role will lead a cross-functional team to gather, analyze, and report on post-market data, make recommendations, and initiate actions accordingly. The role will apply risk management principles to all activities. In addition, this role will support other quality initiatives including, but not limited to, support of design control activities, maintenance of risk management files, and continuous improvement initiatives.
Job Responsibilities and Essential Duties
Minimum Requirements
Required Knowledge, Skills and Abilities
Environmental/Safety/Physical Work Conditions
The physical demands described here are a representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
#LI-DV1
About us
Getinge is on an excitingtransformation journey constantly looking for new ways to innovate together with our customersto meet the healthcare challenges of the future. Our passionatepeople hold our brand promise 'Passion for Life' close to heart.
Ifyoushareourpassionandbelievethatsavinglivesisthegreatestjobinthe world, thenwelook forwardtoreceivingyourapplication and resume. We hope you will join us on our journey to become the world's most respected and trusted MedTec company.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
Getinge 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, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.