Sr. Manager, Manufacturing Engineering, Selution (Irvine, CA)

Overview

MedAlliance, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

The Sr. Manager of Manufacturing Engineering will plan, direct, and coordinate activities of designated project to ensure that goals or objectives of projects are accomplished within prescribed time frame and funding parameters of the manufacturing engineering group by performing the following duties personally or through subordinate supervisors.

Responsibilities

• Interface with Operations Management to review project goals and priorities
• Formulate manufacturing engineering program and organizes staff according to project requirements.
• Oversee and manage Calibration and Preventative Maintenance Department.
• Set strategic direction for Engineering and Calibration & Preventative Maintenance teams to support company goals and objectives.
• Evaluate and approve design changes, specifications, and drawing releases.
• Responsible for hiring, training, and performance management of engineering and maintenance personnel.
• Manage technical activities of engineers and technicians in execution of strategy; assign duties/projects to staff by reviewing/aligning with company goals and objectives.
• Establish performance expectations with employees by reviewing standards and business needs and objectives.
• Coordinate activities to transfer R&D projects into manufacturing. Plan and manage smooth ramp‐up of new products into manufacturing.
• Support company goals and objectives, policies and procedures, and FDA regulations
• Resolve technical issues by hands on approach.
• Lead product / process development projects by creating project plans, establishing objectives and priorities, determining timelines and milestones, and assessing resource requirement.
• Manage engineering resources to resolve Non-Conformances (NC) and/or Corrective Actions/Preventative Action (CAPA) activities. This may include investigation, root cause analysis and/or propose solutions/disposition of materials.
• Assist in complaint investigations (as needed).Perform other duties as assigned.
  
  
  

New Product Development:

• In collaboration with R&D, participate in the development of new product concepts and in the enhancement of existing design and/or process based on customer input and product requirements.
• Provide manufacturing input and requirements for new products in development.
• Develop plan for phasing in new product from R&D to production.
• Participate in brainstorming activities and provide ideas.
• Conduct design reviews as necessary through commercialization of the product.
• Provide input in developing and/or updating the project plan as necessary.
• Prepare test protocols, perform tests and document results, and write the final report.
  
  
  

SUPERVISORY RESPONSIBILITIES:

• Day to day management of Manufacturing Engineers and Technicians.
• Responsible for the overall direction, coordination, and evaluation of the Manufacturing Engineering Team and Calibration & Preventative Maintenance Team function.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  
  
  

Qualifications

• Bachelor’s degree in engineering and 8+ years related work experience, including 2+ years of previous supervisory experience, or equivalent work experience
• 5+ years’ experience in the medical device/pharmaceutical field or in a related area.
• Excellent written and verbal communications skills; ability to interact with and influence all levels of management.
• Ability to review and write/edit technical documents.
• Strong Root Cause Analysis and analytical skills.
• Strong interpersonal skills, effective interaction with Ops and other cross‐functional management to drive projects forward.
• Proficiency in MS Word, MS Project and Excel required.
• High attention to detail and accuracy is required.
• Ability to perform multiple tasks concurrently with accuracy.
• Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
• Work includes potential exposure to chemicals.
  
  
  

Pay / Compensation

The expected pre-tax pay rate for this position is $121,000 – $172,700

Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Why Join Cordis?

For more than 60 years, we have been building interventional vascular technology that offers higher quality and less invasive experiences for people around the world. With a global reach and vast network of resources, we empower you to do your best work and unleash your full potential. Do you want to grow your career surrounded by a supportive team of subject matter experts? Then join us and let’s improve the wellbeing of millions, together.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.