R&D Eng - P3 at Boston Scientific Corporation Malaysia

, , United States -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Engineering, Biomedical Engineering, Quality Systems, Design Control, Data Analysis, Problem Solving, Test Methods, Documentation, Risk Management, Collaboration, Feasibility Studies, Intellectual Property, Manufacturing Techniques, Creative Problem Solving, Statistical Methods, Knowledge Transfer

Industry

Medical Equipment Manufacturing

Description

Working with cross-functional team members, you will help develop strategies for aligning quality systems while maintaining product and business continuity. Responsible for providing mechanical engineering support in the creation and the development of new medical device products (invasive and non-invasive). Partnering with Quality, Process Development, Operations and other cross-functional team members to help develop project integration plans tailored to the unique needs of the product or site. Actively engage in the Discovery phase of design control practices and documentation to identify commonalities and gaps with BSC systems, including prints, CAD, and risk management documents. Aid in developing and subsequently executing design control integration workplans and schedules. Take an active role in the organization to identify and mitigate issues; work cross-functionally to resolve issues and challenges. Assist with developing and implementing knowledge transfer strategy for products and technologies into BSC technical community. Compliance activities may include need for planning and execution of standard based and/or functional performance verification testing. Research, develop, design and evaluate mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment. Actively collaborate with a cross-functional, multi-cultural, global team, often coordinating projects activities or supporting peers in the same. Problem solving through data analysis and use of established investigative tools Conducts feasibility studies to verify product functionality and capability, including identifying failure modes related to design alternatives and product use. Develops test methods and completes test method validations including gauge R&Rs. Maintains detailed documentation throughout all phases of research and development. Investigate and evaluate existing technologies and manufacturing techniques. Collaborate with and provide work direction to test technicians. Communicate scientific data to the technical community and management. Develops new concepts from initial design to market release. Directs support personnel and coordinates project activities. Write and submit intellectual property (patents). Reviews or coordinates vendor activities to support development. May involve travel up to 10% of the time. B.S. in Mechanical or Biomedical Engineering with 4+ years related work experience OR 2+ years related work experience with MS Degree in either of the same fields. Combination drug product design or process experience. Strong mechanical aptitude with a creative unbiased approach to problem solving. Experience working hands-on designing and evaluating test methods and fixtures. Proficiency in basic statistical methods for data analysis Self-starting, independent thinker with strong communication skills Familiarity with a risk-based design controls process to establish design safety and efficacy

Responsibilities

Develop strategies for aligning quality systems while maintaining product and business continuity. Provide mechanical engineering support in the creation and development of new medical device products.