Mech Design Eng - P5

Mech Design Eng - P5

Work mode: Onsite

Onsite Location(s): Dorado, PR, US, 00646

Boston Scientific Neuromodulation technologies help patients manage chronic pain and neurological conditions. Our solutions include WaveWriter Alpha™ Spinal Cord Stimulator (SCS) Systems to treat chronic pain and Vercise Genus™ Deep Brain Stimulation Systems to treat movement disorders such as Parkinson's disease.

There is no one-size-fits-all treatment for pain and neurological conditions. At Boston Scientific Neuromodulation, we're dedicated to working closely with physicians and patients to develop a broad range of solutions that are meaningful, industry-leading, and customizable to improve the quality of life for people across the globe.

About the Role

We are looking for an innovative Prin Mechanical Design Engineer to join our team. You will research, design, develop, and test medical devices. The ideal candidate has a background in mechanical or biomedical engineering and a strong track record of impactful contributions. This role is based in our facility in Dorado Puerto Rico.

Purpose Statement

Responsible for the timely research, design, and development of implantable pulse generator products. Responsibility may be extended to include related system components such as externals or leads. Follows established quality system and procedures during product development. Creatively works to develop products with the highest quality and reliability possible. Provides technical guidance to support personnel such as technicians and assures that their work is performed properly.

Key Responsibilities

Works with physicians, sales, marketing, plus other functional areas to understand and document translated customer needs into requirements specifications.

Acts as project engineer to manage the scope, schedule, and resources for assigned projects.

Actively supports established department plus personal goals and objectives. Monitors project progress and regularly reports progress to manager.

Owns or may contribute to marketing specifications, engineering specifications, feasibility plan/testing/reports, cost estimation/analysis, detailed mechanical engineering design, design reviews, risk analysis, hazard analysis, FMEA-Design/Process/Use, tolerance analysis, material analysis, force analysis, stress analysis, thermal analysis, dynamic analysis, molding analysis, manufacturing equipment definition/debug/validation, tooling definition/debug/validation, process definition/debug/validation, engineering builds, and product verification testing.

Successfully garners necessary project support (internal resources such as manufacturing engineers and technicians; external resources such as test labs, software such as for analysis, equipment and test fixtures such as for pull testing, etc.).

Works to seek approval for viable products or product enhancements that meet or exceed customer needs.

Seeks discovery and development of new technologies or product lines.

Recommends ideas for patent protection/coverage.

Supports ongoing departmental activities such as scheduled meetings, budgeting, screening/interviewing prospective job candidates, etc.

Effective design, development, and project engineering

Meet with and engage physicians, patients, sales reps, marketing, and others to collect feedback for devices under development

Deliver meaningful innovation and submit novel intellectual property

Create specifications and perform engineering analyses

Support creation of project scopes and schedules

Define and validate designs, manufacturing processes, support engineering builds, and verify product performance.

Stay abreast of emerging technologies, trends, and competition.

Deliver designs that meet goals such as performance, standards, manufacturability, reliability, and cost.

Generate regulatory-audit worthy design and risk management documentation

Minimal Qualifications

Education in Mechanical or Biomedical engineering with a B.S. and 8+ years of experience or M.S. and 5+ years of work experience.

Experience as a hands-on design and project engineer in the medical device industry, responsible for new implantable and external device designs, materials, equipment, and processes.

Hands-on experience utilizing SolidWorks 3D CAD and drafting standards (e.g., ANSI Y14.5)

Experience executing projects through commercial launch

Preferred Qualifications

Experience involving/supporting Implantable leads, implantable pulse generators, surgical tools, access instruments, or handheld and wearable devices

Materials biocompatibility

Animal studies, preclinical studies, cadaver lab, field research and clinical studies to evaluate the usability and performance of designed products