Senior Design Quality Assurance - Electrophysiology

Boston Scientific Corporation; Arden Hills (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific Corporation seeks a Senior Design Quality Assurance Engineer for the Electrophysiology portfolio. The role leads quality engineering for sustaining projects and establishes quality systems to meet regulatory requirements.

Hybrid work in Arden Hills, MN requires on-site presence at least three days per week. You will drive compliance activities across design verification/validation, testing, risk management and CAPA while partnering with cross-functional teams to ensure patient

Qualifications

• Bachelor’s of Science in Biomedical, Electrical Engineering or equivalent.
• 6 years of medical device engineering experience, with MEE/MES experience.
• Experience in design verification and validation of Capital Equipment (hardware, software, firmware).
• Regulated environment exposure (FDA, ISO, EUMDR, IEC 60601, EN ISO 14971, IEC 62304, EN ISO 13485).
• Strong leadership, relationship building and team building skills.
• Strong communication and presentation skills.
• Strong applied knowledge of statistical concepts, tools, and methodologies.
• Travel approximately 5-10%.

Responsibilities

• Lead Quality function for product sustaining teams within the Quality System for Medical Electrical Equipment and SUD as part of DQA engineers.
• Provide quality and compliance inputs to project teams for decisions and deliverables (e.g., Design Change Analysis; Design Inputs/Outputs; Test Method Development and Validation; Design Reviews; Verification and Validation; Usability Testing; SW Validation; Process Validation; Labeling).
• Support post market product sustaining activities (non-conformances; CAPA; PIRs; Field Actions).
• Create and maintain safety risk management processes (Hazard Analysis, FTA, Use Error Analysis, Risk Management Plan/Report, DFMEA).
• Collaborate within teams to implement controls meeting internal and external requirements.
• Build quality into all work; maintain compliance with quality requirements.
• Support internal/external regulatory audits as required.
• Other duties as needed.

Skills

Leadership

Communication

Statistics

Regulatory knowledge

Travel

Education

BS in Biomedical or Electrical Engineering

Job description

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Senior Design Quality Assurance - Electrophysiology

Onsite Location(s):

Arden Hills, MN, US, 55112

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role

The Senior Design Quality Assurance Engineer will bring their leadership to sustaining projects for our innovative Electrophysiology cardiovascular products portfolio. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.

Work Mode

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Arden Hills, MN and requires being on-site at least three days per week.

Relocation assistance

No relocation assistance is available for this position at this time .

Boston Scientific may offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities include:

• Lead Quality function for product sustaining teams within the BSC Quality System for Medical Electrical Equipment (MEE) and single use device (SUD) as part of a core group of Design Quality Assurance (DQA) Engineers.
• Provide quality and compliance inputs to project teams for project decisions and deliverables (i.e. Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; SW Validation; Process Validation; and Labeling).
• Provide quality and compliance inputs for post market product sustaining activities, such as design changes, Non-Conformance Reports (NCEP); Corrective and Preventive Actions (CAPA’s); Product Inquiry Report/Field Action Assessment (PIRs); Field Signals Evaluations and Field Actions.
• Create, maintain and/or support safety risk management processes, including Hazard Analysis, Fault Tree Analysis, Task and Use Error Analysis, Risk Management Plan, Risk Management Report, and DFMEA.
• Responsible for collaborating within teams to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Building quality into all aspects of work by maintaining compliance to all quality requirements.
• Support internal and external regulatory audits as required.
• Other duties as necessary or required by the organization.

What we're looking for in you:

Required Qualifications

• Bachelor’s of Science in Biomedical, Electrical Engineering or equivalent.
• 6 years of medical device engineering experience, with experience in Medical Electrical Equipment/Systems (MEE / MES).
• Applied knowledge in the design verification and validation of Capital Equipment, including hardware, software, firmware.
• Experienced in working in a regulated environment for example FDA, ISO standards, EUMDR, IEC 60601, EN ISO 14971, IEC 62304 and EN ISO 13485.
• Strong leadership, relationship building, and team building skills.
• Strong communication and presentation skills.
• Strong applied knowledge of statistical concepts, tools, and methodologies.
• Travel approximately 5-10%.

Requisition ID:637664

Minimum Salary:$85000

Maximum Salary: $161500

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions

It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Nearest Major Market: Minneapolis

Job Segment: Biomedical Engineering, Electrophysiology, Compliance, Quality Assurance, QA, Engineering, Healthcare, Legal, Technology, Quality