Senior R&D; Engineer

Work mode: Hybrid Onsite Location(s): Valencia, CA, US, 91355 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.
Senior R&D Engineer About the role: Provides engineering support for integration activities for an acquisition.
This position is a defined-term role, expected to be completed by the end of 2025.
Provides oversight of the design, quality, manufacturing, and project related activities.
Coordinates with internal functions and external suppliers to identify and execute projects.
Applies project management and problem-solving skills to manage multiple activities concurrently.
Develops products, materials, processes, or equipment for projects of moderate complexity.
Under limited supervision/guidance, compiles, analyzes, and reports operational, test, and research data to establish performance standards for newly designed or modified products, processes, and materials.
10 - 15% domestic and international travel Defined-Term Employee until End of 2025 Your responsibilities include: Ensuring all Design Controls aspects of an acquisition are remediated through: Developing new requirements, sourcing new requirements, creating and validating new test methods, creating new risk documentation, and performing all applicable testing Supporting manufacturing moves from one vendor to another Maintains product safety, quality, and compliance of all products.
Trained in all aspects of change management (DCA, SCIA, SCAR, and PLCP).
Provides oversight of Operations’ manufacturing and quality outputs and takes actions when appropriate.
Supports any applicable R&D projects planning and activities.
Understands and complies with all the regulations governing the quality system.
Supports additional activities required by the business.
What we’re looking for: Basic Qualifications Bachelor’s degree in engineering or another related technical field.
5+ years related work experience.
2+ year’s medical industry experience.
2+ years working with design controls and/or process validation.
2+ year project leader/manager experience.
2+ years working within FDA Quality System Regulations and ISO 13485.
Experience with assessing quality and compliance impact on products for design and process changes.
Experience with design verification and validations activities.
Experience with Test Method development.
Experience in troubleshooting and root cause analysis.
Self-motivated individual that can work independently.
Working knowledge of MiniTab and SolidWorks.
Good writing (assessments, protocols, reports, and email) and verbal communication skills.
Preferred Qualifications Has led 4+ projects to drive product design changes or process changes preferred.
3+ years Electro/Mechanical experience.
Has participated in 4+ new product development projects, related product transfer and scale-up activities preferred.
Knowledge of manufacturing processes including silicone molding, laser welding, resistance welding, small part assembly, cleanroom operations, vision inspection systems, soldering, electronic component assembly, electrical testing and packaging.
Working with international businesses is a plus.
SAP and Windchill experience is a plus.
Pay Transparency Requisition ID: 579837 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life.
Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal.
And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health.
That is why we stand for inclusion, equality, and opportunity for all.
By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific is proud to be an equal opportunity and affirmative action employer.
Boston Scientific maintains a prohibited substance free workplace.
Pursuant to Va.
Code § 2.
2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
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.
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