R&D Engineer

Intellectt INC; Massachusetts; Hybrid; USD 61,000 - 66,000; Full time

Benefits offered by this job

Contract position; no employer-providd

Job summary

Intellectt INC is seeking an experienced R&D Engineer to support a manufacturing transfer project for orthopedic sports medicine devices in Raynham, MA. The role focuses on CCP/CCR leadership, V&V planning, and collaboration with regulatory, quality, and manufacturing teams.

The contract position emphasizes documentation management, PLM usage, and benchtop testing as needed. Onsite work in Raynham is possible with hybrid arrangement.

Qualifications

• BS degree in Engineering.
• 5+ years medical device product development experience.
• Experience with CCP/CCR and leading cross-functional teams.
• Windchill PLM experience.
• Proficient in MS Office.
• Familiarity with Creo CAD.

Responsibilities

• Author and drive Change Control Plans (CCP) and Change Control Reports (CCR); lead cross functional alignment to meet timelines.
• Develop verification and validation (V&V) strategies and rationales, product/package stability strategies, and the Manufacturing Transfer Plan.
• Update requirements and traceability matrices; review and approve process verification and validation activities.
• Use PLM/document management systems to review, route, and manage documents.
• Attend and actively contribute to main team and subteam meetings.
• Support protocol and report generation; if onsite in Raynham, perform benchtop simulated use testing.

Skills

Change Control

Cross-functional collaboration

Documentation

V&V planning

Windchill PLM

Creo CAD

MS Office

Education

BS in Engineering

Tools

Windchill PLM

Creo CAD

MS Office (document mgmt)

Job description

Title: R&D Engineer -Manufacturing Transfer, Orthopedic Sports Medicine Devices

Location: Hybrid - Raynham, MA

Pay Rate: $44/hr - $48/hr DOE

Overview

We are seeking experienced R&D engineers to support a manufacturing transfer project for orthopedic sports medicine devices. The role centers on authoring/managing manufacturing transfer deliverables and leading change control activities while supporting verification/validation and product/package stability strategies. The position requires close coordination with regulatory affairs, quality engineering, and manufacturing teams to deliver on schedule.

Key Responsibilities

• Author and drive Change Control Plans (CCP) and Change Control Reports (CCR); lead cross functional alignment to meet timelines.
• Develop Verification and Validation (V&V) strategies and rationales, Product/Package stability/shelf life strategies, and the Manufacturing Transfer Plan.
• Update requirements and traceability matrices; review and approve process verification and validation activities.
• Use PLM/document management systems to review, route, and manage documents.
• Attend and actively contribute to main team and subteam meetings.
• Support protocol and report generation; if able to be onsite in Raynham, perform and document benchtop simulated use testing (short test events, typically 1 2 days)

Qualifications

• BS degree in Engineering.
• Minimum 5 years' medical device product development experience (R&D experience required); orthopedic device experience preferred.
• Demonstrated experience with change control processes (CCP/CCR) and the ability to lead and facilitate cross functional teams.
• Experience with PLM/document management systems (Windchill highly desirable).
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Strong written and oral communication; organized and detail oriented with the ability to meet project deadlines.
• Windchill PLM experience.
• Familiarity with Creo CAD is interesting, but not required. Familiarity with technical drawings is required.
• Prior authorship of Change Control Plans & Reports, V&V strategies, and stability strategies.

Benefits

This a contract position does not include employer-provided benefits.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to

race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.

Work Authorization

Applicants must be authorized to work in the United States.