Sr R&D Engineer at Boston Scientific Corporation Malaysia

Cartago, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

19 Jan, 26

Salary

0.0

Posted On

21 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Guidance, Project Leadership, Post Market Surveillance, Intellectual Property Development, Regulatory Filings, Design Control Method, Risk Analysis, Design Validation, Verification Plans, Process Improvement, DHF Documentation, DMR Documentation, Statistical Analysis, Biomedical Technology, Analytical Skills, Communication Skills

Industry

Medical Equipment Manufacturing

Description

Responsible for technical input into project level planning. Provide technical guidance to review work plans and advise on unusual features of projects Perform all duties in compliance with the quality management system; actively contribute to the continuous improvement projects. Responsible for technical input into project level planning. Provide technical guidance to review work plans and advise on unusual features of projects Provide technical, project level leadership to engineering assistants or junior engineering staff. Support cross functional team in Post Market Surveillance activities. Support the development of intellectual property where required. Support regulatory filings to various government bodies Bachelor's/Licenciature Degree: Mechatronics, Electronics, Electrical, Mechanical, Materials Science, Biomedical, Industrial, Chemical Engineering or related field. English level: >80%. Experience: >3 years in related positions. Desired knowledge: Design control method such a risk analysis, Desig validation and Verification plans protocol and report generation, PDP TDP system, Process improvement. Experience with guidewire and catheter devices development will be an asset. Knowledge of ISO 13485, ISO 14971, 21 CFR part 820, ISO 11135 and ISO 11607 Experience with drafting and maintaining DHF and DMR documentations Experience with leading rapid design iteration and making design recommendations Ability to independently develops and adapts work plans based on vague or changing project goals Strong hypothesis-driven experimental design and statistical analysis skills Candidates should be self-starters and have a hands-on approach Ability to work independently and within a diverse group of Engineers and Production staff Strong communication skills (verbal/written) and demonstrated leadership skills Possess a strong interest in biomedical technology Self-starter with the ability to quickly learn about new processes Excellent analytical and communication skills (both written and oral) Able to work independently and in a multidisciplinary team environment

Responsibilities

The Sr R&D Engineer is responsible for providing technical input into project planning and guidance on project work plans. They will also support cross-functional teams in various activities, including post-market surveillance and regulatory filings.