Mechanical Product Development Engineer

At Proclinical, we are seeking an individual to fill the role of Mechanical Product Development Engineer, based in Raynham, MA. The successful individual will work in the Product Development team and will make a significant contribution to a cross functional team.

Responsibilities

• Review and approval of documentation to support Technical Document to meet MDR requirements.
• Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
• Participate in cross functional teams to discuss and revise documents to meet MDR requirements
• Create, review and approve engineering rationales/memos as required.
• Independently assess documentation to determine if it meets MDD/MDR requirements (assess gaps), determine best method to meet requirements and execute the plan.
• Ascertain if rationales are required, create or review rationales, approve as required.
• Work towards quarterly goals, provide weekly task updates and project status.
• Suggest means to streamline processes and document approvals.
• Support risk management activities.
• Review and revise design verification and validation documentation, as well as test reports.
• Revise, review and approve verification and validation activities as required.
• Review and approve any required drawing updates, including design impact assessments.
• Review and approve any labeling updates, including design impact assessments.

Skills And Qualifications

• BS degree in Mechanical Engineering, or other technical discipline is required (advanced degree preferred) and 5+ years of related professional experience.
• Strong written, verbal, and interpersonal communication skills.
• Strong proficiency in Microsoft Office required, CAD software and Unigraphics/NX preferred.
• Experience reviewing and approving Change Orders through a PLM System.
• Previous experience with remediation efforts to meet EU MDD/MDR preferred.
• Knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements preferred.
• Working knowledge of material science and mechanical product knowledge preferred.
• Blueprint literacy including GD&T preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matthew Goldberg at (+1) 2674056995 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.