Principal R&D Engineer

Boston Scientific•Carlsbad, CA

29d•$103,700 - $197,000•Onsite

About The Position

Boston Scientific is looking for a Principal R&D Engineer. This person 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).

Requirements

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 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 is strongly preferred. This includes experience with medical device materials 8+ 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.

Nice To Haves

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 resultsâoriented attitude.

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 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 vendors 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.