Sr. R&D Engineer (Onsite at least 3 days a week)

Location: Tempe, AZ • Duration: 9+ months contract • 40 hours/week • Pay rate: $40–55/hr • 1st shift • Onsite at least 3 days per week • Must be local • US citizens or Green Card holders only

About the role

This temporary assignment supports EU-MDR efforts through approximately September 2022. The primary focus is leading EU-MDR submission of products, including product gap assessments, planning, and remediation of gaps within project timelines.

Successful candidates will assist in developing, optimizing, and validating components/elements of a medical device; write technical documents, validation protocols, and reports; prepare work instructions and standard operating procedures; conduct design and process qualification and validation; support test method development and validation; and collaborate with R&D, Quality, Operations, and Regulatory Affairs.

Responsibilities

• Lead all R&D activities surrounding EU-MDR submission of Oncology products, including kits and kit components.
• Coordinate and/or lead all aspects of product remediation related to EU-MDR, integrating RA, QA/QE, Operations, Clinical, Marketing, Sales, and Packaging Engineering.
• Work with cross-functional teams to remediate gaps related to EU-MDR requirements and meet deliverables in line with division and business goals.
• Create, track, and meet project schedules; develop strategic plans and budgets for EU-MDR projects; assess and manage priorities; and lead task completion to ensure project objectives are met.
• Coordinate with team members, internal and external suppliers, and outside professionals to ensure project output meets business needs and applicable regulatory requirements.
• Propose and facilitate product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing.
• Prepare product development plans, lead and participate in design reviews, and approve technical documents and reports.
• Review, approve, and coordinate execution of verification and validation protocols and reports; develop and implement department and division procedures/policies.
• Lead the development of clinically relevant test methods that adequately challenge product design and processes.
• Plan, develop, execute, and manage verification and validation activities for products and processes in support of EU-MDR requirements.
• Train technicians and engineers on design and process development and provide input to training on division procedures and policies.

Requirements

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or other related engineering discipline; Biomedical Engineering or Bioengineering Bachelor’s Degree preferred.
• 4–7 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Master’s degree plus 1–3 years medical device or equivalent industry experience may substitute).
• Demonstrated hands-on technical aptitude.
• Experience in process validation (IQ, OQ, and PQ), writing protocols, and reports to support verification and validation activities for product commercialization; ability to execute validation.
• Ability to create and execute project plans and lead cross-functional teams.
• Basic tooling, design, and drafting knowledge.
• Excellent oral and written communication skills.
• Ability to analyze data, interpret results, and write reports.
• Proficient in statistical software.
• Training in Six Sigma or Design for Six Sigma.

Preferred Qualifications

• Master’s degree in a relevant engineering discipline.
• Knowledge of cGMP and GLP.

Physical Demands

• Regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle, or feel objects, tools, controls, and office equipment.
• Frequently required to verbally communicate with other associates.
• Occasionally required to reach with hands and arms, stoop, kneel, or crouch.
• May work in an open cubicle environment or in preclinical settings such as animal labs, cadaver labs, or attend clinical case observations.