Boston Scientific
Principal R&D Engineer
at Boston Scientific
Join the team and contribute to the design and development of therapeutic medical devices from concept to commercialization. You will lead engineering efforts, mentoring teams, and ensuring quality and regulatory compliance.
About The Role Principal R&D Engineer responsible for design, development, prototyping, analysis, research, manufacturing techniques, go‑to‑market, and manufacturing support for therapeutic medical devices. Expertise in balloon catheters (PTA, PTCA) preferred.
Work Mode Onsite at Carlsbad, CA, 4–5 days per week.
Responsibilities
Utilize research and experience to develop new products 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 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 use 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 vendors and material choices for product.
Identify hazards and mitigate 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 with emphasis on materials engineering preferred. BS considered but experience weighed heavily.
Minimum of 8 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 preferred.
Proficient in CAD software, preferably SolidWorks.
Familiarity with statistical analysis of raw data is required, proficiency in Minitab preferred.
Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and CAD.
Track record of strong cross‑functional collaboration, influence without authority, and project management enabling highly effective project teams.
Preferred Qualifications
Excellent hands‑on mechanical prototyping, verification, and failure analysis skills.
Proficient in Risk Management according to ISO 14971.
Knowledge of ASME Y14.5 GD&T.
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.
Requisition ID:
618928
Minimum Salary:
$103,700
Maximum Salary:
$197,000
At Boston Scientific, we are committed to solving the challenges that matter most. Our mission is to transform 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. We believe in diversity, inclusion, equality, and opportunity for all. Boston Scientific Corporation is an equal opportunity employer and encourages applicants from all backgrounds. This position is safety‑sensitive and requires a prohibited substance test. COVID‑19 vaccination may be required for certain roles.
#J-18808-Ljbffr
at Boston Scientific
Join the team and contribute to the design and development of therapeutic medical devices from concept to commercialization. You will lead engineering efforts, mentoring teams, and ensuring quality and regulatory compliance.
About The Role Principal R&D Engineer responsible for design, development, prototyping, analysis, research, manufacturing techniques, go‑to‑market, and manufacturing support for therapeutic medical devices. Expertise in balloon catheters (PTA, PTCA) preferred.
Work Mode Onsite at Carlsbad, CA, 4–5 days per week.
Responsibilities
Utilize research and experience to develop new products 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 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 use 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 vendors and material choices for product.
Identify hazards and mitigate 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 with emphasis on materials engineering preferred. BS considered but experience weighed heavily.
Minimum of 8 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 preferred.
Proficient in CAD software, preferably SolidWorks.
Familiarity with statistical analysis of raw data is required, proficiency in Minitab preferred.
Experience with mechanical and/or electrical design, mechanical/electrical drawings, tolerance analysis, and CAD.
Track record of strong cross‑functional collaboration, influence without authority, and project management enabling highly effective project teams.
Preferred Qualifications
Excellent hands‑on mechanical prototyping, verification, and failure analysis skills.
Proficient in Risk Management according to ISO 14971.
Knowledge of ASME Y14.5 GD&T.
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.
Requisition ID:
618928
Minimum Salary:
$103,700
Maximum Salary:
$197,000
At Boston Scientific, we are committed to solving the challenges that matter most. Our mission is to transform 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. We believe in diversity, inclusion, equality, and opportunity for all. Boston Scientific Corporation is an equal opportunity employer and encourages applicants from all backgrounds. This position is safety‑sensitive and requires a prohibited substance test. COVID‑19 vaccination may be required for certain roles.
#J-18808-Ljbffr