Boston Scientific Senior Design Quality Engineer 

United States, Minnesota 

780194191

About the role:

The Senior Design Quality Engineer will work cross-functionally to ensure safety, quality and compliance of the device while delivering the highest quality product to the customer. This role will serve as the Quality Team Member on quality engineering methodologies and practices which meet BSC, customer, and regulatory requirements, and offers a unique chance to gain end-to-end exposure to the full Product Life Cycle Process (PLCP) including design, development, integration, and sustaining of Medtech devices.

Your responsibilities will include:

• Function as the Quality Core Team Member
• Provide guidance regarding quality integration strategies and approaches to assessing Design Control and Risk Management related documents and records for potential differences with BSC Quality Systems or compliance gaps
• Assist in determining remediation strategies of acquired entity’s records, as necessary, for Design Control and Risk Management processes
• Collaborate with the integration team to identify and implement compliant and efficient integration plans related to Design Control and Risk Management
• Assess, update and recommend integration activities for Design History File, Design Input / Output, and Risk documentation (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Advise management on potential improvements or enhancement to quality systems and processes in the company, and own actions to implement said improvements

Required qualifications:

• BS in Mechanical / Biomedical Engineering or related discipline or equivalent combination of education and experience to perform at this level
• 5+ years of medical device design control and risk management experience
• Experience leading Design Assurance projects within both New Product Development (NPD) and Integrations
• Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR, and IEC 62366-1 (Usability)
• Ability to relocate to Carlsbad, CA for up to two years

Preferred qualifications:

• Comfortable working ‘in the gray;’ known for innovative, out of the box thinking to identify novel approaches to meeting requirements
• Expertise in providing technical leadership with product strategy – design, development, and integration
• Strong technical knowledge, problem-solving capabilities, collaborative mindset, and effective communication skills
• Experience developing and launching Balloon catheter based medical devices
• Experience with medical device development for single use devices and those containing Electronic Medical Equipment
• Prior experience developing laser-based technologies
• Prior experience supporting or leading integration teams
• 1-2 years’ supervisory experience of technical personnel

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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 specific prohibited substance test 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.