Manufacturing Engineer III Aesthetic Medical Device (Bothell, WA)

Bothell, WA - USA

Monthly Salary: $ 95 - 130

Posted on: 16 hours ago

Vacancies: 1 Vacancy

Job Summary

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 doesnt 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 and has a lead role in the development validation and maintenance of processes and equipment that support Production. This person selects production equipment develops custom equipment and processes as required to produce Solta products. This position is the primary contact for Production Product Development and suppliers as related to process issues.

Responsiblities:

Leads and owns process maintenance and development activities including: planning process definition process limit definition process failure mode effects analysis process validation planning and execution and any process related documentation.
Establishes and maintains production process roadmap.
Works within a cross-functional development team to define and design new products.
Works with Product Development to define production processes during development.
Works with Product Development to ensure manufacturability of products; sets manufacturability criteria and go/no-go recommendations.
Participates in and holds design reviews.
Participates in supplier and subcontractor selection qualification and CAPA efforts.
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.
Leads production equipment selection process.
Creates and maintains all end item BOM structures and production routes.
Performs cost analysis and implements cost reduction plans.
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.
Works with a limited degree of supervision focusing oversight on complex new assignments.

Experience Education Training Traits:

BS in Mechanical Engineering or Electrical Engineering related field or equivalent experience.
Minimum 5 Years experience in a medical device capital equipment manufacturing environment or another regulated environment.
Demonstrated ability to utilize and implement lean manufacturing concepts. Including but not limited to; 5S visual workspace planning A3 problem solving poka-yoke standard work value stream mapping (VSM) kaizen event leadership.
Demonstrated ability to set up manufacturing lines and processes.
Experience assessing process variables utilizing a process failure modes effects analysis (PFMEA).
Demonstrated ability to verify and validate production processes and equipment.
Experience in a box build manufacturing environment.
Demonstrated ability to drive production process improvement through equipment methods and design.
Experience with Creo or other solid modeling tools.
Demonstrated ability to utilize SPC and design of experiments to drive change.
Demonstrated ability to drive DFM improvement into product designs during development.
Working knowledge of medical device FDA QSRs and ISO9001 requirements.
Strong PC skills required Word Excel PowerPoint etc.

The range of starting base pay for this role is $95K-130K. Actual starting pay will be based on a wide range of factors including but not limited to relevant skills experience qualifications education and 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 stock purchase plan 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.

Required Experience:

Responsiblities:

Leads and owns process maintenance and development activities including: planning process definition process limit definition process failure mode effects analysis process validation planning and execution and any process related documentation.
Establishes and maintains production process roadmap.
Works within a cross-functional development team to define and design new products.
Works with Product Development to define production processes during development.
Works with Product Development to ensure manufacturability of products; sets manufacturability criteria and go/no-go recommendations.
Participates in and holds design reviews.
Participates in supplier and subcontractor selection qualification and CAPA efforts.
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.
Leads production equipment selection process.
Creates and maintains all end item BOM structures and production routes.
Performs cost analysis and implements cost reduction plans.
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.
Works with a limited degree of supervision focusing oversight on complex new assignments.

Experience Education Training Traits:

BS in Mechanical Engineering or Electrical Engineering related field or equivalent experience.
Minimum 5 Years experience in a medical device capital equipment manufacturing environment or another regulated environment.
Demonstrated ability to utilize and implement lean manufacturing concepts. Including but not limited to; 5S visual workspace planning A3 problem solving poka-yoke standard work value stream mapping (VSM) kaizen event leadership.
Demonstrated ability to set up manufacturing lines and processes.
Experience assessing process variables utilizing a process failure modes effects analysis (PFMEA).
Demonstrated ability to verify and validate production processes and equipment.
Experience in a box build manufacturing environment.
Demonstrated ability to drive production process improvement through equipment methods and design.
Experience with Creo or other solid modeling tools.
Demonstrated ability to utilize SPC and design of experiments to drive change.
Demonstrated ability to drive DFM improvement into product designs during development.
Working knowledge of medical device FDA QSRs and ISO9001 requirements.
Strong PC skills required Word Excel PowerPoint etc.