Job Details

Assist subject matter experts with writing, reviewing, and/or editing documents required by  design control process, including requirements, risk analyses, specifications, test protocols, and design review checklists.
• Coordinate documentation and Engineering Change Orders (ECOs) related to major design reviews.
• Produce requirements trace mapping and associated documentation.
• Use Siemens Polarion as a tool to accomplish the following:
• Enter and edit documents.
• Create and edit requirements and test cases.
• Create trace links
• Produce reports using standard report templates. Create additional custom reports as needed.
• Produce trace reports.
• Use Agile as a tool to accomplish the following:
• Organize and structure Design History Files (DHF) using Design Control checklists.
• Prepare and submit ECOs for individual documents and for DHF Bill of Material (BOM) changes.
• Work with the Technical Publications department to assure that Manuals, Instructions for Use, Labels and Training Materials are consistent with design documentation. Create trace documents and protocols used to assist in this process.

Skill, Experience, Education and Training:

Minimal Requirements:
• Bachelor’s Degree in engineering or other technical area
• Ability to understand complex technical information and translate into writing
• Proven success recognizing critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction.
• Ability to manage challenging assignments and multiple assignments in parallel
• Strong planning, decision making, negotiating and change management skills
• Assertive, outgoing personality with an ability to work collaboratively within an engineering team
• Excellent writing and communication skills.
• A high attention to detail.
• Skilled in the use of Microsoft Excel, Microsoft Word, and Adobe Acrobat

Preferred Requirements:
• Minimum 3 years’ experience working in an ISO 9001 medical device product development environment or other regulated industry
• Experience writing and reviewing engineering (design control) documents, including specifications, test protocols and test reports
• Skilled in the use of Agile or similar lifecycle management system tool
• Skilled in the use of Integrity, Polarion or other requirements management tool
• Development experience with complex systems with a combination of hardware and software
• Experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs)