Sr. R&D Engineer; Onsite

Client: Medical Device Company

Position: Sr. R&D Engineer

Location: Tempe, AZ

Duration: 9+ Months contract

Total Hours/week: 40.00

Shift: 1st Shift

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Preferred Work Type: Onsite at least 3 days a week. Must be local

Restrictions: No H1B’s

This position is a temporary assignment that will support EU‑MDR efforts and is anticipated to last approximately through September 2022. Primary focus of this position is to lead 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; assist in conducting design and process qualification and validation; support test method development and validation, and support other activities from R&D, Quality, Operations, and Regulatory Affairs.

• Support EU‑MDR submissions: lead all R&D activities surrounding EU‑MDR submission of oncology products, including kits and kit components.
• Product Remediation: coordinate and/or lead all aspects of product remediation activity related to EU‑MDR, including integration of 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 all deliverables in line with division and business goals.
• Project Management: create, track and meet project schedules; create 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.
• Design to Manufacturing Transfer: propose and facilitate product updates in line with EU‑MDR requirements while maintaining design intent and smooth transfer to manufacturing.
• Documentation: prepare product development plans, lead and participate in design reviews, approve technical documents and reports; review, approve and coordinate execution of verification and validation protocols and reports; develop and implement department and division procedures and policy.
• Test Method Development: lead the development of clinically relevant test methods that adequately challenge product design and processes.
• Testing: plan, develop, execute and manage verification and validation activities for products and processes in support of EU‑MDR requirements.
• Training: train technicians and engineers on design and process development and provide input to training of division procedures and policies.

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering Bachelor’s Degree preferred.
• Experience:
  
  4‑7 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 1‑3 years medical device or equivalent industry experience).
• 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.
• Ability to 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.

• Master's degree in relevant engineering discipline.
• Knowledge of cGMP and GLP is a plus.

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to…