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Job

R&D EUMDR Product Engineer

  • Job ref:

    12432

  • Location:

    Trumbull, United States

  • Sector:

    Mechanical Engineers

  • Contact:

    Dan Dubay

  • Published:

    10 months ago

  • Consultant:

    #

Job Description

Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.

We are currently seeking a R&D EUMDR Product Engineer in Trumbull, CT.

 

Position Summary and Special Duties:

As a R&D EUMDR Product Engineer your day to day duties will consist of and may not be limited to:

The right candidate will lead EU-MDR Transition and remediation efforts for product technical files to meet new EU MDR (EU) 2017/745 regulations and respective standards, be comfortable in a fast-paced environment, and derive satisfaction from knowing that their efforts ultimately lead to improved quality of life for patients.

 

 

EUMDR Product Engineer is responsible to drive the creation, updates, and execution of technical documentation, such as: specifications and engineering drawings, useability, biocompatibility, material properties, CMR substance reports, cleaning validation, sterilization validation, DIOVV, shelf-life, packaging, labeling, ship testing, useful life testing, functional testing, and clinical data. This position is a technical expert in all aspects of Design History File and CE Technical File and will use a life-cycle approach as a systematic process for establishing a sound and useable set of technical documents tightly integrated into Design Controls.  The position is responsible for ensuring that project objectives are met accurately and on time for CE submission according to established Regulatory and Business Strategy.

 

 

Requires understanding of ISO 14971:2019 Risk Management including implementation of the company’s quality system processes related to CE technical files to include risk management, Failure Modes and Effects Analysis (FMEA), Risk Plans, and Risk Reports. 

 

In addition, this position may be responsible to identify root causes (RCA) and corrective actions related to internal nonconformities, product complaints, and supplier quality issues.  This position may be involved in special projects such as new product development.

 

RESPONSIBILITIES: 

  • Maintains knowledge of relevant internal and external quality and regulatory standards and works to meet changing requirements, including the Medical Device Regulation (MDR), US FDA 21 CFR 820, MDSAP and others as required. 
  • Drive design control compliance by ensuring that all applicable safety, quality and regulatory guidelines and policies for are followed to develop safe and effective medical devices.
  • Accountable for meeting quality objectives, Quality Policy and is also accountable to ensure the company’s technical documentation is established and maintained in accordance with required regulatory standards. 
  • Creates test protocols, runs experiments and writes test reports
  • Verifies and validates key design inputs and complex requirements
  • Performs measurement system analysis
  • Coordinates testing with approved vendors
  • Supports Production Operations and collaborates closely with Quality in efforts to drive product and process improvement while minimizing risk, as well as efforts to improve profitability. 
  • Implements problem solving methodologies and troubleshoots to reduce internal and external defects.
  • Provide engineering insight and guidance on EU-MDR Transition and remediation efforts product development, product improvement and process improvement projects. 
  • Identifies and implements product and process controls consistent with the outcome of the risk management process. 
  • Search and retrieve documents to fulfill requirements.
  • May support the PAR/PTR (Product Acquisition Record / Product Transfer Record) Process for medical devices
  • May participate in the selection, interviewing and hiring process of consultants, contractors, or regular employees. 

 

STRATEGY:

 

Responsible to develop and implement strategies and processes to ensure local technical documentation is created and maintained in accordance with regulatory standards (FDA, MDR, etc.)  Implements strategy to improve product and process quality through the implementation of quality and reliability engineering principles. 

 

 

SPECIFIC KNOWLEDGE & SKILLS REQUIREMENTS: 

 

  • Strong in-depth working knowledge of medical device regulations including 21 CFR 820, EU MDR 2017/745 and other global regulatory requirements and quality system standards including ISO14971:2019, ISO 13485, IEC 60601 and other relevant standards. 
  • Previous experience in design engineering, product/process engineering, manufacturing engineering and/or quality engineering within the Medical Device Industry.
  • Medical device development experience with thorough understanding of design control guidelines including verification, validation methods and test system development and implementation.
  • Expertise in CAD modeling (SolidWorks preferred), mechanical design and creation of engineering drawings and documentation including GD&T.
  • Previous experience in the creation of all aspects of technical documentation related to Design History Files and CE Technical Files. Familiar with FDA 510 (k) submissions.
  • Proficiency with design of experiments, protocol and model development, testing and documentation.
  • Practical experience with the implementation of statistical tools and techniques. 
  • Must have a sound understanding of the QMS and related sub-systems interactions.
  • Previous success in driving improvement through root cause analysis and CAPA projects. 
  • Strong understanding of best practices related to supplier quality and supplier development. 
  • Experience with translating customer to product requirements, conducting harm-based risk analysis and defining acceptance criteria.
  • Hands-on craft skills and experience with building, fixing, servicing and/or fabricating concepts, fixtures, prototypes or similar.
  • General knowledgeable in computer system validation and related regulatory requirements.

 

 

GENERAL SKILLS & COMPETENCIES: 

 

  • Ability to design, structure, plan and manage complex projects in matrix organization; understand resources utilization, develop practical project timelines, budgets, assign tasks and areas of responsibility.
  • Excellent planning and organizational skills and techniques.  Experience with SCRUM management methodology a plus.  Work independently with minimal direction.
  • Outstanding verbal and written communication skills.
  • Communicate effectively with management and upper management.
  • Excellent presentation and public speaking skills. Ability to interact, cooperate personally & technically on a global basis
  • Excellent independent decision making including tactical execution skills.
  • Understand and act on financial information that contributes to business profitability, optimization, and maximization.
  • Good negotiating skills and ability to effectively interact, influence and manage outsourced technical resources
  • Multi-tasking environment and ability to work under and adhere to specific deadlines
  • Experience interacting with all functions within a business.
  • Demonstrated success with analysis and problem-solving methods, tools & techniques
  • Ability to utilize common office and web-based software (email, spreadsheets, word processing, presentations) effectively.

 

EDUCATION: 

 

A Bachelor's Degree in Engineering, typically Electrical, Mechanical, or Biomedical. Master's Degree in Engineering or Science, an MBA or global equivalent a plus.

 

MINIMUM WORK EXPERIENCE: 

•           7+ years in the medical device industry:

Typically, 7 or more years of Engineering and R&D Design Control experience within the medical device industry, including roles within product development, sustaining engineering, or manufacturing engineering, as well as direct experience with processes related to the creation of Design History File and CE Technical File documentation. 

 

DETAILS:

  • Duration: Direct Hire
  • Location: Trumbull, CT
  • Salary: Direct Hire
  • Benefits: Full Benefits

Qualified candidates are encouraged to apply immediately!

Please include a clean copy of your resume and salary expectations and any references.

 

Submit resumes to: dan.dubay@lighthouseprofessional.com