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Technical Writing Supervisor at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Writing, Leadership, Regulatory Compliance, Project Management, Documentation, Collaboration, Attention to Detail, Communication Skills, Document Management Systems, Risk Management, Post-Market Surveillance, Medical Device Knowledge, Quality Systems, Design History Files, Microsoft Office, Team Development

Industry

Medical Equipment Manufacturing

Description

Lead, mentor, and develop a team of technical writers by investing in their growth, creating clear development paths, and cultivating a supportive, collaborative environment where individuals can thrive and advance their careers. Contribute to the development and cohesion of the broader Technical Writing organization at the Arbor Lakes site, helping to align best practices, share knowledge, and strengthen engagement. Oversee the creation and maintenance of product technical documentation, including design history files (DHF), risk management deliverables, and post-market surveillance deliverables. Collaborate with R&D, Quality, Regulatory Affairs, and Marketing teams to gather technical content and ensure alignment across functions. Manage high-impact documentation projects in a fast-paced environment, including recall- or field action-related deliverables. Support regulatory submissions and audits by providing compliant and accurate documentation. Bachelor's degree in Technical Communication, Engineering, Life Sciences, or a related field. 5+ years of experience in technical writing within the medical device, pharmaceutical, or another regulated industry. 2+ years of experience in a leadership or supervisory role. Strong understanding of regulatory and quality system documentation (FDA 21 CFR 820, ISO 13485, ISO 14971, MDR). Excellent written and verbal communication skills. Proficiency with document management systems (e.g., Windchill, Agile PLM) and Microsoft Office authoring tools. Exceptional attention to detail and project management skills. Experience supporting peripheral or coronary medical device products. Experience authoring design history, risk management, and post-market surveillance documentation.

Responsibilities

Lead and mentor a team of technical writers while overseeing the creation and maintenance of product technical documentation. Collaborate with various teams to ensure alignment and support regulatory submissions and audits.