R&D Documentation Specialist

Additional Location(s): Canada-QC-Montreal

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.                

About the role 
The R&D Documentation Specialist will manage and coordinate controlled documents using an electronic system, handle engineering and design change notices, and ensure timely updates to engineering documentation. Furthermore, they will review documentation for accuracy, facilitate Change Control Board requests, and train team members on document control procedures.

Your responsibilities will include:

• Create, coordinate, and maintain all controlled document files using an electronic system.
• Copy, distribute and maintain documents in accordance with company procedures.
• Review final version of documentation changes for any potential issues and work with engineers to resolve them.
• Develop, receive, and review process engineering changes notices (CNs) and design change assessments (DCAs).
• Change Notice (CN) Process: Process CN through various stages of the CN process. This may include CN creation, Submission Review; Implementation, and Document Issuance (Manages the distribution of documents as needed).
• Interpret and implement corporate documentation requirements as they relate to local documentation requirements.
• Coordinate Change Control Board Documentation requests:
  • Ensure engineering documentation is changed in a timely and accurate manner.
  • Ensure new part numbers are created utilizing established naming conventions, product structures are developed, and parts being changed are clearly flagged to support engineering changes and new product releases.
  • Review CN packages for completeness and accuracy.
  • Ensure CNs are prepared and distributed to functional areas as defined by the CN process.
• Inform the appropriate individuals when CNs are approved to facilitate a smooth change or introduction.
• Aid in training personnel regarding document format, content, use, control, and the document control system.

Required qualifications:

• Bachelor’s degree or equivalent in a related field.
• 3-5 years related experience in the medical device industry.
• 2+ years’ experience managing documentation and complex activities.
• Experience managing multiple electronic documentation systems and processing documents and drawings for approval.
• A knowledge and understanding how regularly available information is developed and maintained including drawings, design specifications, AML/AVLs and internal bills of material (BOMs).
• Experience managing electronic documentation systems and processing documents and drawings for approval.
• Excellent organizational, communication and collaboration skills.
• Excellent documentation skills.

Preferred qualifications:

• Experience using electronic document systems such as Windchill.
• Ability to work under limited supervision and manage multiple tasks and prioritize assignments with limited time constraints while working consistently in a fast-paced environment.
• Flexibility and ability to adjust to changing priorities and unforeseen events.

Requisition ID: 585820

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.