Product Engineer

Job Title: Junior Medical Device Product Engineer (Documentation Focus)

Location: Danvers, MA (Hybrid: 2-3 Days Onsite Per Week)

Job Type: Contract (Until End of Year)

Job Overview:

We are seeking a Junior Medical Device Product Engineer with a strong background in medical device documentation. This role is not a Project Manager or Project Engineer position but is primarily focused on maintaining and managing technical documentation for medical device projects. The ideal candidate should have 3-6 years of experience in the medical device industry and be highly detail-oriented with a solid understanding of FDA/ISO regulatory requirements.

Key Responsibilities:

• Develop and manage the Software Design History File (DHF).
• Maintain JAMA/WRIKE (similar to Jira) tools and generate documentation for the Design History File (DHF).
• Support project documentation and materials management via SAP.
• Assist with backlog grooming and maintenance.
• Track project documents to analyze the successful completion of short- and long-term goals.
• Organize and conduct document reviews with stakeholders and development teams.
• Ensure adherence to quality standards and regulatory requirements throughout the project lifecycle.
• Support Design Assurance Engineering activities for Software Product Development and Software Life Cycle Processes.
• Assist in quality planning, design reviews, test method development, verification & validation (V&V) test plans, and post-market monitoring.
• Drive project deliverables, ensuring alignment with company SOPs and regulatory standards.

Qualifications:

• Bachelor’s Degree in Engineering/Technology or related field.
• 3-6 years of experience in the medical device industry (Mandatory).
• Strong documentation experience in the medical device field (Mandatory).
• Experience with Medical Device Software Systems and Cardiovascular Devices preferred.
• Class III medical device experience is strongly preferred.
• Working knowledge of FDA/ISO regulatory requirements.
• Proficiency in documentation tools such as JAMA, WRIKE (or Jira), and SAP.
• Self-motivated, highly organized, and detail-oriented with strong analytical and problem-solving skills.
• Excellent verbal and written communication skills, with the ability to collaborate with cross-functional teams.

Additional Information:

• Must be local to Massachusetts and able to commute to Danvers, MA (2-3 days onsite per week).
• Contract through the end of the year with potential extensions.
• Competitive hourly pay rate ($36-$48 per hour), based on experience.
• This role is documentation-focused and not a Project Manager or Project Engineer position.

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