Mech Design Eng - P4 at Boston Scientific Corporation Malaysia

, , United States -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Engineering, Biomedical Engineering, Project Management, SolidWorks, Design Development, Regulatory Compliance, Risk Management, Product Development, Engineering Analysis, Manufacturing Processes, Clinical Studies, Biocompatibility, Innovation, Patent Protection, Customer Engagement, Feedback Collection

Industry

Medical Equipment Manufacturing

Description

Works with physicians, sales, marketing, plus other functional areas to understand and document translated customer needs into requirement 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 report progress to manager. Successfully garners necessary project support (internal resources such as manufacturing engineers and technicians; external resources such as test labs). Works to seek approval for viable products or product enhancements that meet or exceed customer needs. Creatively works to develop products with the highest quality and reliability possible. 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 Education in Mechanical or Biomedical engineering with a B.S. and 5+ years of experience or M.S. and 3+ 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 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

Responsibilities

The role involves collaborating with various stakeholders to translate customer needs into specifications and managing project scope, schedule, and resources. The engineer will also support product development and innovation while ensuring compliance with quality and regulatory standards.