Boston Scientific Senior Quality Product Engineer 

United States, California, Irvine 

861577865

About the role:

Responsible for providing technical acumen and leadership to the Irvine, CA Sacral Neuromodulation manufacturing site with a significant focus on production / operations quality. This will include support for in-process inspection, final inspection, final product release activities, and will lead investigation and resolution of nonconformances. This role will also support post-acquisition quality systems integration activities as well as product transfer projects.

Your responsibilities will include:

• Developing and implementing quality inspection procedures including sampling plans, for production level components, sub-assemblies and finished goods. May also be responsible for the development and implementation of inspection methodologies, fixtures, measurement systems and calibration of such.
• Providing input regarding appropriate statistical methods, test methodologies, test facilities and equipment. Coordination of testing and management of resulting documentation and records. This can include process validation, equipment installation/operational qualification, test method validation, etc.
• Conducting product and process nonconformance investigations and may include NCEP & CAPA ownership.
• Mentoring junior engineers and investigators by providing technical guidance in identifying and resolving quality issues using engineering essentials and other related problem-solving tools and techniques.
• Ensures compliance with company quality policies and practices by participating in product and material reviews, assist in resolving problems related to the Manufacture, test, validation, and documentation.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required qualifications:

• Bachelor’s degree in Engineering or other related scientific discipline
• Minimum of 3 years of related experience
• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO13485 Quality Standards.

Preferred qualifications:

• Experience in Medical Device industry
• Demonstrated effective change leadership and results-oriented focus
• Demonstrated problem-solving & data analysis capabilities
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences
• Ability to collaborate and influence across multiple, cross-functional teams
• Strong ability to successfully multi-task and adaptability
• Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.
• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
• Self-starter with the ability to identify improvement opportunities.
• Comfort speaking to groups of individuals including divisional senior leaders. Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.

Maximum Salary: $ 164500

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.