Principal R&D Engineering Lead

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 Principal R&D Engineering Lead will be a key contributor to the design and development of a therapeutic medical device, from concept to early human use to commercialization. The Engineering Lead will work closely with the team to drive all aspects of the development process including conceptualizing, prototyping, analysis (physical and simulation), researching manufacturing techniques, go-to-market implementation, and manufacturing support. The ideal candidate will possess some knowledge of balloon catheters (i.e., PTA, PTCA).

Work Mode

At Boston Scientific, we value collaboration and synergy. This role requires employees to be in our local office in Carlsbad, CA five days per week.

Visa Sponsorship

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your Responsibilities will Include:

• Utilize research and experience to develop new product and processes to increase performance.
• Manage multiple projects simultaneously, on time, well documented and within budget to meet business objectives.
• Collaborate with external suppliers for component and process design and identify outsourcing opportunities.
• Provide technical leadership and maintain the engineering staff’s knowledge of technology and engineering areas associated with instrument and mechanism design and manufacturing processes.
• Understand the technology and key product features that ensure clinical and commercial success
• Manage research and development activities from Concept Phase through Commercialization
• Make data driven decisions using appropriate analytical methodologies
• Prepare for and conduct various design reviews in accordance with product development
• Demonstrate deep insight regarding design intent and uses insight to drive product requirements and specifications. Develop processes necessary to fabricate devices. Develop and implement test methods for assessing the quality of in-process and finished products.
• Develop, execute, and analyze design verification and validation studies, culminating in a design history file.
• Prepare documentation to support quality system for design functions (project plans, concept document, FMEA, design input, test results, drawings, etc.)
• Provide technical leadership along with technical subject matter expertise to product development team.
• Conduct preclinical build operations as necessary.
• Initiate, define, perform and execute verification and validation activities.
• Prepare technical documentation, including manufacturing instructions, test methods, drawings, BOMs, protocols, and reports to support design control activities.
• Perform risk analysis activities and develop product testing plans and protocols; set up and run product testing and protocols in accordance with project plans
• Research and recommend vendor and material choices for product
• Identify hazards and mitigates risk associated with identified hazards in Design and Process FMEA. Assess failure modes and conduct technical risk analysis.
• Comply and analyze data, identify causes, draw conclusions, generate reports.
• Create and manage a schedule of technical deliverables in coordination with a project manager.
• Translate highly technical results into easily understood recommendations that will influence cross-functional and senior stakeholders.

Required Qualifications:

• MS/PhD degree in Materials Science, or Mechanical Engineering w/emphasis on materials engineering preferred. BS in one of those fields will be considered but will be weighed heavily on work experience.
• Minimum of 7 years of experience in medical device engineering.
• Polymer knowledge along with extrusion, injection molding experience and metallurgy.  
• Knowledge of and exposure to product testing and data collection
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD
• Working knowledge of mechanical design principles and FDA class 3 regulated medical device design controls.
• Medical Device experience in new product development with successful design from concept to commercialization is strongly preferred. This includes experience with medical device materials 7+ years product development, preferably in medical device industry.
• Proficient in CAD software, preferably SolidWorks.
• Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred.
• Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and computer-aided design (CAD)
• Track record of strong cross-functional collaboration, influence without authority, and project management enabling highly effective project teams.
• Knowledge, Skills, and Abilities:
• Excellent hands-on mechanical prototyping, verification, and failure analysis skills.
• Proven self-starter who runs towards critical issues, ambiguous requirements, or loosely defined challenges with a demonstrated ability to rally teams to achieve business results.
• Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA).
• Strong leadership skills and mentoring capabilities
• Strong quantitative analysis and problem-solving skills and methodologies
• Strong interpersonal and communication skills (oral/presentation and written)
• A flexible team player, focusing on shared goals with a positive results‐oriented attitude.

Preferred Qualifications:

• Proficient in Risk Management according to ISO 14971.
• Knowledge of ASME Y14.5 GD&T.

Requisition ID: 616744 

Minimum Salary: $ 99100 

Maximum Salary: $ 188300 

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.

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 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 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.