What you’ll be doing:
Implements the company's Production function including any of the following activities: production planning/coordination, shift scheduling, material requirements, planning systems, work-in-process tracking, material and labor variance controls, and manufacturing performance reporting in a Class III regulated manufacturing environment. Responsible for planning, reviewing, and developing production procedures and personnel.
Who we are:
Here at Tandem, Diabetes is all we do and we are dedicated to making the lives of people with diabetes better and better, through relentless innovation. “In Tandem” means together, and we strive to embody that in every aspect of our business. We believe that working in tandem, not in isolation, is the best way to continually exceed expectations.
We’ve have been named one of the fastest growing insulin pump companies in the U.S! Why? Designed, assembled and supported from our San Diego, CA headquarters, Tandem has created the simple-to-use t:slim X2 Insulin Pump, which is the smallest pump available, the only color touch-screen insulin pump capable of remote feature updates, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger.
Read more about our company & culture here: https://www.tandemdiabetes.com/careers/life-at-tandem and see what our customers are saying here: #tsliminthewild
What you need for this position:
PRIMARY DUTIES & RESPONSIBILITIES:
- Manages production to meet Operations requirements.
- Coordinates efforts between manufacturing and other departments (Engineering, QA/QC, and Purchasing/Planning) to achieve objectives.
- Tracks and delivers successful results for key performance measures
- Clever focus on improving and maintaining productivity and ensuring processes have minimal downtime
- Reduce expenses and eliminate waste across all product lines
- Ensures the effective use of material, equipment and personnel in producing quality products.
- Establishes short-term plans and objectives to meet current manufacturing requirements.
- Ensures department staff is properly trained, per designated training plan, before assuming job responsibilities
- Participates in the selection, development, performance appraisal, merit recommendation, and promotion of department staff.
- Develops and manages schedules and performance requirements of staff.
- Ensures all employees follow industry standard health and safety guidelines
- Establish workflow policies that enhance speed and efficiency without compromising product safety or integrity.
- Supports the short-term planning for the department including headcount, budgeting, training, and systems requirements
- Promotes process improvements by developing and implementing programs to improve manufacturing output or quality.
- Develops plans for new product introductions by working with R&D and Manufacturing Engineering
- Evaluates area procedures and operations to ensure that efficient and effective methods are in place to promote the manufacturing of a quality product.
- Ensures that the designated area is in compliance with cGMP Regulations for Class III device, area documentation and standard operating procedures are accurate and up to date, and that a readiness for regulatory agency audits exists at all times.
- Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
- Knowledge, skills & abilities:
- Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
- Strong knowledge and application of principles outlined in Quality System Regulations (QSRs/GMPs) and manufacturing of a Class III device.
- Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others.
- Skilled at developing and maintaining a manufacturing team that is proficient in the use of small scale mechanical assembly tools (Torque wrenches, screwdrivers, tweezers, dispensers, etc)
- Skilled at developing and maintaining a manufacturing team that is proficient with high volume automation equipment (Robots, conveyors, uptime and equipment utilization considerations, etc)
- Personally proficient in the use of common assembly tooling including hand soldering.
- Proficient with Microsoft Office, general computer related interface systems, and Manufacturing Execution Systems (MES).
- Minimum certifications/educational level:
- S. degree in Science or Engineering or a related field, or equivalent combination of education and applicable job experience.
- Minimum experience:
- 15 years’ experience in Medical Device Manufacturing of Class III devices.
- 15 years’ experience in a production management role.
- Lean Manufacturing experience
- 6-Sigma Black Belt
- Experience with production and inventory control software (e.g. ERP).
- Successful experience effectively leading an assembly team is required.
- Experienced with high volume automation assembly
- Experienced with supervising electrical mechanical assembly work
- Experienced in production management role with company(s) having revenue in excess of $500M per year
- Participates with others in senior management to establish strategic plans and objectives for the functional area. Develops methods, techniques, and evaluation criteria for projects, programs, and people.
- Works on complex issues where analysis of situations or data requires an in-depth knowledge of functional area and related organizational objectives.
- Erroneous decisions will have a serious impact on the overall success of functional, division, or company operations.
What’s in it for you?
We’ve got you covered. We offer a robust benefits package to support your health and your family. From medical, dental, and vision, to flexible spending accounts for both health and dependent care – Tandem’s got you covered!
Stay well with us. Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails. Or check out our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.
Invest in your career. Tandem offers all employees access to training and development programs and courses to help keep your career and skillset updated, not outdated.
Live your life. Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. Save for your future with a company-provided 401(k) plan. Look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more with our exclusive employee discount program.
Celebrate in Tandem. Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick’s Day, costume-contest for Halloween, and the annual JDRF walk.