How you'll make a difference?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.
What will your duties and responsibilities beThe following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.
- 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.
What skills and experience will you need?The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.
Education/Certifications: - Minimum Bachelor's Degree in Engineering
Experience, Skills, Knowledge and/or Abilities:- 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.
What qualifications are preferred?The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.
Education/Certifications: - Master's Degree in Engineering (Biomedical or Mechanical preferred)
Additional Experience, Skills, Knowledge and/or Abilities:- Spine/Orthopedic device experience
- CAD experience (Pro-Engineer/Creo, SolidWorks, or equivalent)
- Human tissue processing
- Lyophilization experience
- Familiar with Aseptic processing
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONSThe physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.
- This position requires frequent exposure to chemicals and/or solvents.
The anticipated salary for this position for an employee who is located in California is $165,000 to $190,000 per year, plus bonus, and benefits.
DISCLAIMER The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.
