R&d Documentation Specialist

6 months ago

Montréal, Canada Boston Scientific Corporation Full time

**Work mode**:Hybrid**Onsite Location(s)**:Montreal, QC, CA**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- 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.-
**Job Segment**:R&D Engineer, R&D, Document Control, QC, Engineer, Engineering, Research, Administrative, Quality

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