Sr. Manager, Manufacturing Engineering
About The Position
The Sr. Manager - Manufacturing Engineering is responsible for leading new process development activities for all R&D and complex manufacturing projects. They will also lead the team supplying daily support to all areas of the Irvine Operation. The Sr. Manager will facilitate team development, budget, planning, and continuous improvement activities on an ongoing basis. The Sr. Manager will draw upon established expertise to help their team achieve solutions to a variety of complex technical problems. This role will work cross functionally across the entire organization in order to ensure projects and tasks are completed with high quality and on time.
Requirements
- Minimum Bachelor’s Degree in Engineering
- 10+ years’ experience in medical device manufacturing.
- At least 2 years of leadership experience, inclusive of hiring and coaching experience.
- Ability to generate and maintain a budget.
- Expertise in FDA QSR and ISO 13485 principles, including Design Controls and Risk Management.
Nice To Haves
- Master’s Degree in Engineering (Biomedical or Mechanical preferred)
- Spine/Orthopedic device experience
- CAD experience (Pro-Engineer/Creo, SolidWorks, or equivalent)
- Human tissue processing
- Lyophilization experience
- Familiar with Aseptic processing
Responsibilities
- Builds and develops engineering talent and teams.
- Leads business critical design projects to develop and commercialize Orthobiological medical products and devices.
- Establishes project plans, develops product requirements, and coordinates other team activities in accordance with Design Control and Risk Management procedures.
- Effectively collaborates with interdepartmental personnel and external partners to uphold project plans and achieve project objectives.
- Provides timely project updates to the leadership staff on a recurring basis.
- Generates and analyzes test data and reports to verify that designs meet functional and performance specifications.
- Stays current with industry standards by attending networking, training, or other developmental seminars.
- Interfaces with vendors regarding technical issues while supervising designs throughout the manufacturing process.
- Provides training, mentorship, and supervision to junior engineering and product development staff.
- Develops intellectual property based on developed products.
- Leads departmental meetings as scheduled.
- Performs other duties as assigned.
Benefits
- bonus
- benefits
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What This Job Offers
Job Type
Full-time
Career Level
Manager
