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Design Quality Engineer
Ref No.: 18-04145
Location: Raynham, Massachusetts
Start Date: 04/13/2018
OVERALL RESPONSIBILITIES:
Working in the Design Quality team the qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take action, and have excellent written and verbal communication skills. Candidate will support efforts to ensure EU MDR compliance. Must have a strong compliance background and experience with Medical Device Regulations.
POSITION DUTIES & RESPONSIBILITIES:
  • Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
  • Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
  • Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.
  • 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.
  • Deliverables to be quarterly based on assigned files.
  • Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
  • Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
  • Provide leadership in the understanding of medical device regulations to other disciplines.
  • Ability to work in a team setting within Design Quality and cross-functionally is required.
  • Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing.
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
  • Report task progress and status on a weekly basis.

EDUCATION & EXPERIENCE REQUIREMENTS:
  • A minimum of Bachelor's degree in engineering or related technical or scientific discipline with a minimum of 5 years of experience in related field are required.
  • Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management are required.
  • Proven track record implementing Quality System improvements to meet compliance and overall business goals.
  • Change control experience (reviewing and approving design engineering change orders through a PLM System) is required
  • Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.) is required.
  • Candidate should possess excellent problem solving, decision-making, and root-cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.
  • Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.
  • Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.
  • Previous experience in a medical device or a healthcare discipline is preferred.
  • Previous Quality Engineering experience is preferred.
  • Working knowledge of material science and mechanical product knowledge is preferred.
  • Development and/or manufacturing experience is preferred.
  • Blueprint literacy including GD&T is preferred.
  • Knowledge of process and design excellence tools is preferred.
  • This position will be based in Raynham, MA