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Senior Manufacturing Engineer

2 months ago

Santa Clara, California, United States Cirtec Medical Corporation Full time
Job Overview

This role is situated within a dynamic and innovative environment.

ABOUT CIRTEC MEDICAL CORPORATION

Cirtec Medical Corporation is not merely a design firm or contract manufacturer; we provide a comprehensive suite of vertically integrated services. Our expertise lies in the production of intricate components and devices utilizing cutting-edge technologies, particularly in the fields of neuromodulation, implantable drug delivery, cardiac rhythm management, and interventional devices. We possess the capabilities necessary to transition products into full-scale production, encompassing assembly, packaging, testing, and in-house sterilization.

Our team is composed of skilled professionals dedicated to designing innovative medical devices, addressing complex design challenges, and facilitating the market introduction of our clients' products. If you seek a stimulating and fast-paced work atmosphere with a growing company at the forefront of technology, Cirtec is the ideal place for you.

YOUR ROLE:

You will be an integral part of the engineering team, collaborating closely with colleagues from Operations, R&D, and Purchasing. Your responsibilities will include the design, development, documentation, and validation of new customer products, as well as modifications to existing products. This will involve defining requirements, timelines, and deliverables, with a focus on prototypes, process development, design verification, clinical builds, and preparation for process validation and manufacturing transfer.

POSITION SUMMARY

As a Manufacturing Engineer at Cirtec Medical, you will play a crucial role in the development of manufacturing processes, the launch of new products into clinical and pilot production, and the support of ongoing production activities.

We are in search of a Manufacturing Engineer who can contribute innovative ideas and creative solutions, particularly for catheter-based devices. Your primary focus will be on maintaining, developing, and implementing cost-effective manufacturing processes and methods. You will provide daily support for manufacturing operations from an engineering perspective, documenting processes, implementing improvements, and driving investigations related to non-conformances. Your work will span both early-phase development products and established products in sustained production.

KEY RESPONSIBILITIES

  • Design and implement efficient, cost-effective manufacturing processes while enhancing product flow and quality.
  • Oversee the transition of new products to production, including setting assembly time and yield targets, identifying training needs, and ensuring quality control.
  • Create, test, and implement tools, fixtures, and equipment necessary for manufacturing processes.
  • Develop manufacturing process instructions, inspection plans, and documentation for product history.
  • Lead the creation of manufacturing process validation plans and protocols, ensuring compliance with validation requirements.
  • Collaborate with cross-functional teams during the development phases, providing insights for design for manufacturability (DFM).
  • Maintain process risk documentation (e.g., PFMEA) to identify potential risks and implement corrective actions.
  • Support maintenance, qualification, and calibration of production and testing equipment.
  • Conduct analyses for cost reduction and improvements in quality and efficiency.
  • Prepare engineering change orders and coordinate the implementation of changes, including staff training.
  • Investigate defects, determine root causes, and implement effective solutions.
  • Manage non-conforming products and develop necessary rework procedures.
  • Communicate with stakeholders regarding process enhancements and production modifications.
  • Perform additional responsibilities as assigned.

To excel in this position, candidates must be capable of fulfilling the essential duties and responsibilities outlined above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this role.

QUALIFICATIONS

  • Bachelor's degree in Mechanical, Biomedical, or Industrial Engineering, or a related engineering discipline.
  • A minimum of 2 years of experience in medical device process development or manufacturing engineering.
  • Familiarity with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies is preferred.
  • Experience with new product introduction processes.
  • Solid understanding of GMP and ISO 13485 regulations.
  • Ability to review and interpret technical drawings and specifications; proficiency in Solidworks is a plus.
  • Strong computer skills, including proficiency in the MS Office suite.
  • Fluency in English, with excellent written and verbal communication skills.
  • Demonstrated organizational skills to manage multiple priorities and schedules effectively.

WHAT WE PROVIDE

  • A dynamic and fast-paced work environment.
  • Paid time off benefits.
  • 401(k) retirement savings plan with company matching.
  • Well-maintained and safe production areas.
  • Opportunities for training and career development, including onboarding programs and tuition assistance.
  • Competitive compensation and benefits packages, including health care and wellness programs.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Employer.

Cirtec Medical Corporation is committed to hiring qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status, or any other factor prohibited by law. We fully endorse equal opportunity for all and provide reasonable accommodations for qualified individuals with disabilities and disabled veterans in the job application process.

The compensation range for this position is between $100,000 and $125,000 annually, with the starting base pay determined by job-related skills, experience, qualifications, work location, and market conditions.