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Working in the Product Development team the qualified candidate for this 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 cross functional team, must be self-motivated to take action, and have excellent written and verbal communication skills. Candidate will support design verification & validation efforts and design control activities for development programs and/or updates of existing technical documents to meet MDR requirements. Must have medical device product development experience and experience with Medical Device Regulations.
POSITION DUTIES & RESPONSIBILITIES:
Responsible for development and execution of design verification and validation plans and activities, and test plan formation and execution to support global regulatory strategy.
Generate new or revise existing design control documentation. Documents to include (not limited to) Risk Management (design and process), validation, product drawings, performance testing, trace matrix, material specifications, biocompatibility reports, CER (Clinical Evaluation Report), IFUs, surgical technique, manufacturing process information
Support risk management activities including planning, design & clinical risk management DFMEA, production riskmanagement PFMEA, and overall risk summary reporting.
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 and in creation of project plans.
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.
Work towards project goals, provide regular task updates and inform on project status.
Suggest means to streamline processes and document approvals
Review and approve any required drawing updates, including design impact assessments.
Review and approve any labeling updates, including design impact assessments.
Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
Know and follow all laws and policies that apply to one's job, and maintain the highest levels ofprofessionalism, ethics and compliance at all times.
EDUCATION & EXPERIENCE REQUIREMENTS:
• Experience with all the design and development aspects of a series of projects through all phases of the product development process; planning and executing projects or portions of projects from concept through commercialization, and into post-market surveillance.
• Position requires the ability to understand and review the product development outputs for user needs and clinical requirements; as well as, associated verification and validation activities. Candidate must have knowledge of product development documentation requirements and the manufacture of medical instruments and implants to meet the needs of surgeons & patients.
• This individual will also be involved with the creation, review and/or revision of design verification and validation documentation and test reports that support regulatory review for US and global registration effort.
• Must be experienced with product design and all components of product design including documentation for design controls and Design History Files.
• Must have a strong compliance background and experience with Medical Device Regulations.
• Candidate must also possess knowledge of applicable ASTM/ISO standards (i.e., biocompatibility standards). Engineer will need to ensure standards are appropriate and review documentation of evidence that the standards are met and documented appropriately.
• This individual should have a demonstrated ability to prioritize tasks and manage a varied workload, exhibit strong written and verbal communication skills and interface effectively with project teams, management and surgeons.
• A minimum of a Bachelor's of Science degree in Mechanical Engineering, or other technical discipline is required. An Advanced Degree is preferred.
• A minimum of 5 years of professional experience in engineering is required (not including co-op, internship and research). Prior experience in Product Development role is required.
• Experience working within a regulated industry is required; and Medical Device, Spine or Clientpedic experience is preferred.
• The ability to work and execute projects tasks within a cross functional environment is required.
• Prior experience working cross functional project teams, bringing products from concept to launch, is preferred.
• Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.
• Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.) is required.
• Knowledge of CAD software is preferred; Unigraphics/NX is preferred
• Experience reviewing and approving Change Orders through a PLM System (Adaptiv,WindChill) is 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.
• Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.
• Working knowledge of material science and mechanical product knowledge is preferred.
• Blueprint literacy including GD&T is preferred.
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