R-D Engineer I

12-month contract with potential for extension. W2 contract; candidates must be legally authorized to work in the United States and able to sit on Primary Talent Partners W2 without sponsorship. ACA-compliant supplemental package available for enrollment.

About the role

This engineer will support the PTA and Procedural Support portfolio within the client’s R&D Released Product Management (RPM) team in the Peripheral Vascular Health Operating Unit. The role involves execution of product and process development activities, technical documentation, validation efforts, and cross-functional collaboration. This position is ideal for an engineer who is eager and quick to learn, enjoys hands-on technical work, and is motivated by contributing to projects that directly impact patients.

The role offers a flexible work style that may include a combination of onsite and remote work. Flexible arrangements are not guaranteed and may change based on business needs and facility space. Future adjustments could include transitioning to full-time onsite.

Responsibilities

• Support execution of technical strategies and deliverables for the PTA and Procedural Support portfolio within the R&D RPM group.
• Execute and support test strategies, including development, coordination, and completion of testing activities.
• Perform hands-on laboratory and product evaluation work to build technical understanding of products and associated therapies.
• Develop understanding of product functionality through test methods (TM), technical documentation, and product evaluations.
• Execute Test Method Validations (TMVs) in accordance with applicable procedures and regulatory requirements.
• Support Production Part Approval Process (PPAP) activities and associated documentation requirements.
• Route, review, and approve technical reports while ensuring compliance with Quality Management System (QMS) procedures and documentation standards.
• Collaborate with Regulatory Affairs to understand submission strategies and support regulatory documentation needs.
• Support cross-functional teams to ensure project timelines, compliance requirements, and operational objectives are achieved.
• Design, develop, analyze, troubleshoot, and provide technical skills during research and/or product development.
• Design studies to investigate specific life science questions within field of expertise; may be involved in product research and development and/or clinical trials.
• Translate research discoveries into usable and marketable products.

Differentiating Factors

• Autonomy: Entry-level individual contributor on a project or work team; works with close supervision.
• Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
• Innovation and Complexity: Identifies, defines, and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
• Communication and Influence: Communicates primarily with internal contacts within immediate group. Contacts others to gather, confirm, and convey information.
• Leadership and Talent Management: Focused on self-development.

Requirements

• Bachelor’s degree (minimum) in Engineering or Scientific discipline.
• 0-2 years of technical engineering experience.
• Strong technical writing, analytical, and problem-solving skills.
• Working knowledge of QMS requirements and document control processes.
• 0-2 years of experience with testing and data analysis, creating test protocols and reports.
• Engineering experience in medical device, regulated manufacturing, or related industry.
• Experience supporting TMVs, PPAPs, IQ/OQ/PQ activities, or equipment validations.
• Experience with validation activities, technical documentation, and regulated quality systems.
• Familiarity with design verification, test methods, equipment qualification, or process validation.
• Hands-on laboratory or manufacturing support experience.

Top Skills

• Strong analytical and problem-solving skills.
• Strong technical writing skills.
• Eager and quick to learn.

Main Day-to-Day Activities

• Support execution of technical strategies and deliverables (design verification testing, design/technical documentation) for PTA and procedural support products within the R&D released product portfolio.
• Execute test strategies, including development, coordination, and completion of testing activities.
• Support cross-functional projects in manufacturing, quality, or regulatory in relation to device design.

Pay

$30.00 - $40.00/hr

Schedule

Hybrid - 3+ days in office required