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Senior Manufacturing Engineer
Qapel Medical Fremont, CA
$118k-140k (estimate)
Full Time 0 Months Ago
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Qapel Medical is Hiring a Senior Manufacturing Engineer Near Fremont, CA

Company Description

Who is Q’Apel?

In the simplest sense, we’re a company that creates solutions. More specifically, we design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. That’s where we come in.

Our name was inspired by the Qu’Appelle River, a waterway that winds through Saskatchewan, Canada, highly tortuous in some areas and straight in others. The field of stroke care is similarly riddled with challenges and barriers practically unmatched in any other field of medicine. And over the years, there have been innovators who’ve dared to design solutions for stroke care.

But there’s one invaluable ingredient often missing: a commitment to creating what works based specifically and urgently on what’s needed. We’re Q’Apel, and we work side by side with neurovascular specialists who have dedicated their careers to serving stroke patients. The result? Solutions that get straight to the heart of what’s needed now, and the momentum to solve what’s coming next.

Job Description

You will contribute to the design, development, and manufacturability of Q’apel’s innovative and fast-growing line of neurovascular/ vascular products. Our strategic advantage is our technology, time to market and people. You will be joining a high-performance team that consistently brings winning products the market. We are proud of our customer focused reputation we have earned from our customers and are looking for energetic motivated individuals to join our rapidly growing team.

This role is multifaceted and varied; it will require you to have technical knowledge for assigned products so that you will be able to assure the design will meet customer and regulatory needs. You will head up the design transfer to manufacturing to assure the product can be manufactured and is cost effective/ within budget. We will rely on your design, development, verification, and validation testing expertise to contribute to keep the team on schedule as schedules are tight.

Position Responsibilities and Authorities:

  • Provide engineering expertise to the design, fabrication, development, installation, validation and qualification of equipment /fixtures per Quality system requirements.
  • Ability to set up and run product testing and protocols in accordance with project plans. 
  • Design, specify, assemble and validate manufacturing equipment and processes.
  • Identify and support the qualification of suppliers for materials needed for products. 
  • Ensure product documentation is in accordance with the Quality Management System requirements. 
  • Provide manufacturing engineering expertise in the daily operation and maintenance manufacturing processes and related business continuity needs in production.
  • Troubleshoot manufacturing processes and equipment.
  • Work with Quality Engineering and Production personnel in the conduct of root cause analyses of material and process non-conformances (NCMRs) and implementation of corrective actions (CAPAs).
  • Work with R&D and Production personnel to manufacture product for Design Verification and to transfer new products and processes into manufacturing environment in-house or to an external contract manufacturer.
  • Lead engineering testing and documentation that complies with regulatory requirements for regulatory approval or clearance by FDA or other international regulatory bodies, as required. 
  • Support the Quality System and Quality Policy. Be compliant with Quality System procedures and requirements, including regulatory requirements, and training requirements. Initiate corrective actions regarding concerns involving product quality as needed. 
  • Other duties as assigned

Qualifications

Qualification Requirements:

Education: BS Degree in Engineering or related discipline or equivalent related experience in the medical device industry. 

Experience & Skills:

  • 7-10 years’ experience in an engineering or related experience in the medical device industry, preferably in the Neurovascular/ Vascular device industry. Strong preference will be given to those with experience with Catheters
  • Knowledge of FDA regulations, guidelines and policy statements. 
  • Knowledge of international regulations, standards, and guidelines such as MDD, ISO 13485, Risk Management)
  • Effective/ Excellent verbal and written communications
  • Project management experience and detailed project planning is desirable
  • Familiar with Design Control procedures and requirements.
  • Ability to work independently or in a team setting required. 
  • Communicating effectively across all levels of the organization
  • Works well under pressure, organized and self-motivated
  • Use of critical thinking, problem solving and analysis
  • Use of statistical experimental design and analysis techniques. Working knowledge of Statistical Process Control (SPC), Six Sigma principals and tools and decision-making tools
  • Use CAD software such as Auto cad, Solid works
  • Ability to travel to contract manufacturer, attend training activities, and visit suppliers, etc. will be required periodically.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Job Summary

JOB TYPE

Full Time

SALARY

$118k-140k (estimate)

POST DATE

03/07/2023

EXPIRATION DATE

06/05/2023

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