Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
This position is responsible for the maintenance and continuous improvement of manufacturing processes at Solta Medical and its Contract Manufacturers as they relate to product quality, delivery, efficiency, and cost. This position is the primary contact for Production, Product Development, and suppliers as related to process issues.
Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
Manages process maintenance activities including planning, process definition, process limit definition, process failure mode effects analysis, process validation planning and execution, and any process related documentation.
Participates in the design transfer from engineering to manufacturing.
Performs production capacity planning and manufacturing line layout activities.
Develops and maintains manufacturing assembly instructions, tooling, and other aids to ensure a controlled and efficient manufacturing process.
Develops process and equipment verification and validation plans, reports, etc.
Participates in production equipment selection process.
Creates and maintains all end item BOM structures and production routes.
Performs data analysis and trending on manufacturing processes.
Initiates root-cause analysis and troubleshooting and improvement activities to increase quality and yields and reduce cost.
Experience, Education, Training, Traits:
BS in Mechanical Engineering or Electrical Engineering, related field, or equivalent experience.
Experience directly supporting manufacturing operations, preferably with electronics device manufacturing.
Familiarity with process failure modes effects analysis (PFMEA).
Experience in process verification and validation.
Demonstrated ability to drive production process improvement through equipment, methods, and design.
Experience with Creo or other solid modeling tools.
Strong PC skills required Word, Excel, PowerPoint, etc.
Effective communication and documentation skills.
A self-motivated and results-oriented individual.
Desired skills:
Understanding of lean manufacturing concepts
Experience troubleshooting electronic equipment and processes.
Experience in a medical device capital equipment manufacturing environment or another regulated environment.
Working knowledge of medical device FDA QSR's and ISO9001 requirements is highly desired.
Background in RF and laser equipment and/or diagnostic or therapeutic ultrasound.
Demonstrated ability to coach and train production personnel.
Language and Verbal Skills
Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and status to project team members.
Math Skills
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to use MS Excel or Minitab to perform calculations and interpret project results/data.
Analytical and Reading Skills
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to read regulatory, technical and clinical literature and documents and extract important concepts.
Physical Requirements
While performing the duties of this job, the employee may be required to perform lifting tasks of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.
Work Environment
The work environment is office and light manufacturing. The noise level in the work environment is usually moderate. Some light machining and prototyping activities will involve moderate noise levels (i.e. power drill) and moderate dust or debris exposure.
Safety
Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.
The range of starting base pay for this role is 73K-100k. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.
Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, , Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
