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

Position Summary

This position is a temporary assignment that will support EU-MDR efforts and is anticipated to last approximately through September 2022.

Essential / Key Job Responsibilities (including supervisory and/or fiscal)

• Support of EU-MDR submissions: leads all R&D activities surrounding EU-MDR submission of Oncology products, including kits and kit components.
• Product Remediation: coordinates and/or leads all aspects of product remediation activity related to EU-MDR, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering. Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals.
• Project Management: creates, tracks and meets project schedules. Creates strategic plans and budgets for EU-MDR projects, assesses and manages priorities and leads task completion to ensure project objectives are met. Coordinates with team members, internal and external suppliers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements.
• Design to Manufacturing Transfer: proposes and facilitates product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing.
• Documentation: Prepares product development plans, leads and participates in design reviews, approves technical documents and reports. Reviews, approves and coordinates execution of verification and validation protocols and reports. Develops and implements department and division procedures/policy.
• Test Method Development: leads 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.

Required Qualifications

• 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 statistic software.
• Training in Six Sigma or Design for Six Sigma.

Preferred Qualifications

• Masters degree in relevant engineering discipline.
• Knowledge of cGMP and GLP is a plus.