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R&D Engineer
R&D EngineerSynectics • Irvine, CA, United States
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R&D Engineer

R&D Engineer

Synectics • Irvine, CA, United States
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  • serp_jobs.job_card.full_time
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Duties :

  • Working with engineers on fixtures
  • Performing analysis
  • Doing assembly work
  • Fixture developing
  • Focused on device and combination of products
  • Supplier management

Qualifications :

  • B.S. in Mechanical, Biomedical, Industrial Engineering discipline
  • Master's degree
  • Technical : Direct experience in Design development of combination products, or Medical Devices.
  • Working knowledge of system engineering, risk management, usability, all the phases of design controls (end to end), global regulatory submissions, high volume manufacturing of devices and packaging including biologics.
  • Experience with plastic- injection molding, glass, rubber, hypodermic syringes will be highly desired.
  • Strategic : Ability to make timely, high-quality decisions with less than perfect information and apply good engineering principles.
  • Sets clear and concise strategies and robust implementation plans ensuring business and patient impact.
  • Effective communication across all the levels within the organization to drive collaboration and decision-making.
  • Business : Ability to develop trade-off scenarios impacting business areas.
  • Direct experience in designing and analyzing using 3D, 2D and FEA.
  • Direct design control, risk management, test method development, & testing experience in Combination products, Medical Devices.
  • Create, maintaining specification, protocol, and reports.
  • Clear and concise written and verbal communication cross functionally.
  • Ability to prioritize and adapt in rapidly changing environment and stakeholders need.
  • 5-8+ years in regulated industry
  • Statistical analysis.
  • Usability and Regulatory experience.
  • Prototyping
  • Sets clear and concise strategies and robust implementation plans ensuring business and patient impact.
  • Ability to develop trade-off scenarios
  • Design for Six Sigmas
  • 8+ years direct experience in Product Development within Pharma, BioPharm, or Medical devices.
  • Solidworks
  • California Fair Chance Act :

    Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov / fair-chance-act / .

    Benefits :

    Healthcare Insurance : Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

    Dental Insurance : Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

    Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

    Technical Certification Bonus : Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

    Synectics is an equal opportunity employer.

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    Rd • Irvine, CA, United States

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