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OMEC supplies high quality products with advanced functionality for Medical Surgery and Biomedical Diagnostic industry that leverage our expertise with optical instrumentation design and commercialization.
Title: Quality Assurance Manager/Director
Salary: $80,000 - $120,000 a year
Job Type: Full-Time
About the role:
Establish a quality center of excellence, develop organizational strategies, processes, goals, and metrics to drive measurable improvements in quality processes. Oversee the consistency of quality processes. Manage and address potential product and safety investigations through investigation and corrective action.
Qualifications and Requirements:
Required：
➢ BS in Engineering or other relevant field.
➢ 10+ years of full time Quality Assurance experience in ISO 13485 environment.
➢ 3+ years in Quality Assurance Management.
➢ Formal training in Quality Systems.
Preferred:
➢ Ideally someone with a demonstrated track record of Quality (special focus on design and customer quality), design assurance and/or R&D function or equivalent achievements.
➢ Skilled in building a team and managing the team to deliver the highest quality products and solutions in a timely manner.
➢ Skilled in providing a strategic direction and tactical focus to the Quality Assurance organization and influence the direction of divisional QA activities (specifically Design and Customer Quality).
➢ Skilled in launching new products with high quality and ensuring quick resolution to quality issues on launched products as well as work closely with several functions including salesforce, marketing, R&D, product engineering, field service, operations etc.
➢ Skilled in representing quality processes during internal and external audits.
➢ Skilled in analyzing and resolving non-routine product issues using independent judgment.
➢ Must be able to routinely make decisions which affect immediate operations and may have a company-wide effect.
➢ Must be willing to travel (25%) and spend time in the operating room, and animal labs and visit customers or teams in other geographies as needed.
➢ Must have excellent interpersonal skills.
Benefits:
➢ 401(k) with company match
➢ Medical Insurance
➢ Dental Insurance
➢ Vision Insurance
➢ Paid time off
➢ Paid sick leave
➢ Paid Holidays
Supplemental pay types:
➢ Bonus
Language: Chinese (preferred)
Work Location: Two locations
Work Remotely： No
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Title: Manufacture Engineer/Senior Engineer
Salary: $55,000 - $90,000 a year
Job Type: Full-Time
About the role:
➢ Develop and implement improved methods of manufacturing, procedures, and processes that result in improved efficiencies, yields, machine operations, and quality.
➢ Implement project or improvement plans for areas of responsibility including but not limited to: efficiency improvements, cost reduction or quality improvement programs, new product support and other process improvements.
➢ Perform lot and equipment dispositions to support the continuous flow of production.
➢ Identify systematic problems in either process or equipment related sources and communicating findings to the engineering staff in a continuous manner.
➢ Support the manufacturing ramp with execution of equipment/process startup, process experiments.
➢ Participate in data analysis and problem resolution.
Qualifications and Requirements:
Required：
➢ Bachelor’s degree (B.S.) in engineering (electrical, mechanical, or industrial), physics, or chemistry required. Preferred:
➢ Ideally someone with experience working in a regulated environment such as ISO 13485.
➢ Experience in an optomechanical manufacturing environment preferred.
➢ Competent in evaluating manufacturing processes based on quality criteria, such as efficiency and speed preferred.
➢ Competent in designing and installing equipment preferred.
➢ Competent in organizing and managing manufacturing workflows and resources preferred.
➢ Competent in resolving issues and delays in production preferred.
➢ Experience in training staff in new and existing processes preferred.
➢ Competent in collaborating with other engineers, contractors and suppliers preferred.
➢ Experience in ensuring that manufacturing procedures follow safety and environmental regulations preferred.
➢ Ability to occasionally work late shifts and travel preferred.
Benefits:
➢ 401(k) with company match
➢ Medical Insurance
➢ Dental Insurance
➢ Vision Insurance
➢ Paid time off
➢ Paid sick leave
➢ Paid Holidays
Supplemental pay types:
➢ Bonus
Language: Chinese (preferred)
Work Location: One location
Work Remotely： No
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Title: R/D Manager/Director
Salary: $85,000-$150,000 a year
Job Type: Full-Time
About the role:
➢ Participate and influence the design of the next generation medical system from the ground up.
➢ Work collaboratively with electrical, software, firmware, controls and clinical teams to implement creative design solutions.
➢ Lead the definition, conceptualization, prototyping, and testing of various modules.
➢ Utilize rapid prototyping capabilities to evaluate and de-risk designs.
➢ Lead technical design reviews to gather feedback, identify risks and generate consensus.
➢ Use Design for Manufacturing principles to reduce cost and simplify assembly.
➢ Generate novel ideas that strengthen the company’s position by generation of invention disclosures.
➢ Mentor and guide junior engineers.
Qualifications and Requirements:
Required：
➢ MSc. Or PhD degree in engineering or applicable technical field (electrical, mechanical, optical instrument or biomedical Engineering preferred).
➢ 10 years industry experience with at least 5yrs in biotech, or medical device, or photonics.
➢ 3 years in Engineering Management (R&D, or Process Development).
Preferred:
➢ Ideally someone with a demonstrated track record of design, process problem-solving achievements.
➢ Experience in an optomechanical engineering environment is must.
➢ Experience working in a regulated environment such as ISO 13485 preferred
➢ Key Knowledge: Optics / Mechanical / Photoelectrical sensor (high speed) preferred.
➢ Accomplished in leading a team of R&D Engineers to execute technical projects on business continuity, custom interface, value improvement, compliance, or emergent highrisk projects on commercialized products preferred
➢ Accomplished in developing and/or Refining the V&V approach that ensures changes still meet design intent preferred.
➢ Understanding Medical Device Design Control and Risk Management.
➢ Skilled in providing R&D support for capacity increase, continuous improvement, or cost reduction goals preferred.
Benefits:
➢ 401(k) with company match
➢ Medical Insurance
➢ Dental Insurance
➢ Vision Insurance
➢ Paid time off
➢ Paid sick leave
➢ Paid Holidays
Supplemental pay types: Bonus
Language: Chinese (preferred)
Work Location: One location
Work Remotely: No
OMEC Medical NV Inc. 5690 Riggins Ct, Suite B, Reno, NV 89502 Tel: 408-373-2132
E-Mail: HR@omecmedical.com |
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