Know ATS Score
CV/Résumé Score
  • Expertini Resume Scoring: Our Semantic Matching Algorithm evaluates your CV/Résumé before you apply for this job role: Design Transfer Engineer.
United States Jobs Expertini

Urgent! Design Transfer Engineer Job Opening In North Chicago – Now Hiring Collins Consulting Inc

Design Transfer Engineer



Job description

This is an onsite position.

Local candidates.



Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market.

Responsible for assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.

Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, Eyecare Products, Aesthetics Devices, etc.



Responsibilities


  • Primary driver for the quality and compliance aspects of Design transfer and on-market change management.

  • Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of the client.

  • Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.

  • Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor to ensure timely closure.

  • Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.

  • Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.

  • Assist 3rd party suppliers during change management process, including change management strategies.

  • Identify gaps in existing processes as well as the need for new processes.

    Lead cross-functional teams for solution development and implementation.

  • Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.

  • Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at the client s plants as well as contract manufacturing and supplier facilities.

    Implements agreed strategy.

  • Make recommendations for key decisions on product quality, compliance and regulatory conformance issues.

  • Establish and maintain relationships and open communication with suppliers, contract manufacturers, the client s plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.

  • Initiate assignments independently.

    Actively lead and participate on development and process improvement teams.

    Anticipate/resolve quality issues and take preventative actions.

  • Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements.

    Write/review policies/processes/procedures and related documents.

  • Conduct, lead, or participate in investigations and review boards for Change Plans, CAPAs, NCRs, Observations, etc.




Qualifications

  • Bachelor s degree in Science, Engineering, or other technical areas; or equivalent job experience required.

    Advanced degree preferred; ASQ certification preferred (CQA, CQE, SSBB, etc.)

  • 8+ years of relevant experience in the medical device industry; at least 5+ years in Quality Assurance experience required.

  • Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR 820, EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR).

  • Working knowledge of international standards and regulations applicable to medical devices and combination products.

  • Experience with medical devices and/or combination products such as infusion pumps, PFS, Autoinjector, or Eyecare Products preferred.

  • Ability to apply practical and technical problem solving to quality system and product improvements.

  • Excellent interpersonal skills, including ability to work effectively cross-culturally and cross-functionally.

  • Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.

  • Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives.

  • Champions high quality deliverables, innovation, and appropriate risk-based decision making; Ability to understand the sensitivities within the client s environment.

  • Excellent project management and interpersonal skills.

  • Adaptable to changes in work environment.

  • Ability to work in a fast-paced environment.


The benefits that you are eligible for with Collins Consulting, Inc:

  • 401(k)

  • Medical, Dental and Vision Insurance

  • Term Life Insurance

  • Accidental Death and Dismemberment

  • Long Term Disability


Required Skill Profession

Engineers



Your Complete Job Search Toolkit

✨ Smart • Intelligent • Private • Secure

Start Using Our Tools

Join thousands of professionals who've advanced their careers with our platform

Rate or Report This Job
If you feel this job is inaccurate or spam kindly report to us using below form.
Please Note: This is NOT a job application form.


    Unlock Your Design Transfer Potential: Insight & Career Growth Guide


  • Real-time Design Transfer Jobs Trends in North Chicago, United States (Graphical Representation)

    Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Design Transfer in North Chicago, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 18901 jobs in United States and 332 jobs in North Chicago. This comprehensive analysis highlights market share and opportunities for professionals in Design Transfer roles. These dynamic trends provide a better understanding of the job market landscape in these regions.

  • Are You Looking for Design Transfer Engineer Job?

    Great news! is currently hiring and seeking a Design Transfer Engineer to join their team. Feel free to download the job details.

    Wait no longer! Are you also interested in exploring similar jobs? Search now: .

  • The Work Culture

    An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Collins Consulting Inc adheres to the cultural norms as outlined by Expertini.

    The fundamental ethical values are:
    • 1. Independence
    • 2. Loyalty
    • 3. Impartiality
    • 4. Integrity
    • 5. Accountability
    • 6. Respect for human rights
    • 7. Obeying United States laws and regulations
  • What Is the Average Salary Range for Design Transfer Engineer Positions?

    The average salary range for a varies, but the pay scale is rated "Standard" in North Chicago. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

  • What Are the Key Qualifications for Design Transfer Engineer?

    Key qualifications for Design Transfer Engineer typically include Engineers and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.

  • How Can I Improve My Chances of Getting Hired for Design Transfer Engineer?

    To improve your chances of getting hired for Design Transfer Engineer, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

  • Interview Tips for Design Transfer Engineer Job Success
    Collins Consulting Inc interview tips for Design Transfer Engineer

    Here are some tips to help you prepare for and ace your job interview:

    Before the Interview:
    • Research: Learn about the Collins Consulting Inc's mission, values, products, and the specific job requirements and get further information about
    • Other Openings
    • Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.
    • Dress Professionally: Choose attire appropriate for the company culture.
    • Prepare Questions: Show your interest by having thoughtful questions for the interviewer.
    • Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.
    During the Interview:
    • Be Punctual: Arrive on time to demonstrate professionalism and respect.
    • Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.
    • Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.
    • Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.
    • Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.
    • Follow Up: Send a thank-you email to the interviewer within 24 hours.
    Additional Tips:
    • Be Yourself: Let your personality shine through while maintaining professionalism.
    • Be Honest: Don't exaggerate your skills or experience.
    • Be Positive: Focus on your strengths and accomplishments.
    • Body Language: Maintain good posture, avoid fidgeting, and make eye contact.
    • Turn Off Phone: Avoid distractions during the interview.
    Final Thought:

    To prepare for your Design Transfer Engineer interview at Collins Consulting Inc, research the company, understand the job requirements, and practice common interview questions.

    Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Collins Consulting Inc's products or services and be prepared to discuss how you can contribute to their success.

    By following these tips, you can increase your chances of making a positive impression and landing the job!

  • How to Set Up Job Alerts for Design Transfer Engineer Positions

    Setting up job alerts for Design Transfer Engineer is easy with United States Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!