Senior Process Engineer, Advanced Operations

Tempe, AZ - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

Strykers Sustainability Solutions Advanced Operations team is seeking to hire a Senior Process Engineer Advanced Operations to work on new product introduction process development in Tempe AZ. This role supports the execution of assigned project elements with an emphasis on the manufacturing process technology and procedures required for the manufacture of new products.

What you will do-

Provide engineering support for new product and process introductions ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures
Assist in the selection and design of equipment based on analysis of specifications reliability and regulatory requirements with a focus on identifying opportunities for automation to improve efficiency improve capacity and/or reduce product cost
Ensure quality of process and product as defined in the appropriate operation and material specifications
Support capital acquisition activities including specifying equipment contract negotiation installation and validation
Write operations manuals troubleshooting manuals continuous and preventive maintenance manuals
Analyze equipment to establish operating data and conduct experimental test and result analysis
Use engineering techniques to reduce product time to market whilst adhering to regulatory requirements project deadlines and product costs
Participate in process review meetings
Participate in process failure mode and effect analysis (PFMEA) control plan standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches
Complete capability studies for in-process inspection and generate subsequent inspection documentation
Conduct qualifications validations and measurement system analysis (MSA) studies for new products and new processes. Review and approve validation documentation
Workin a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development
Drive and execute effective communication with all stakeholders to enable project success
Provide training for manufacturing team members
Ensure adherence to GMP and safety procedures

What you need-

2 years of relevant work experience required
Bachelors degree in engineering required
Bachelors degree in Electrical Engineering highly preferred
Experience with programmable logic controllers (PLC) ladder logic and/or other similar programming languages highly preferred
Understanding of control system wiring and wiring diagrams highly preferred
Lean Six Sigma Green Belt Certification or above preferred
Knowledge of manufacturing processes materials product and process design preferred
Good understanding of design for manufacturing (DFM) related statistical tools and validation/verification techniques preferred
Experience writing and executing validations preferred
Experience in new product introduction or manufacturing engineering preferred
Experience in an FDA regulated or regulated industry preferred

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.

Required Experience:

Senior IC

Work Flexibility: HybridStrykers Sustainability Solutions Advanced Operations team is seeking to hire a Senior Process Engineer Advanced Operations to work on new product introduction process development in Tempe AZ. This role supports the execution of assigned project elements with an emphasis on t...

Work Flexibility: Hybrid

What you will do-

Provide engineering support for new product and process introductions ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures
Assist in the selection and design of equipment based on analysis of specifications reliability and regulatory requirements with a focus on identifying opportunities for automation to improve efficiency improve capacity and/or reduce product cost
Ensure quality of process and product as defined in the appropriate operation and material specifications
Support capital acquisition activities including specifying equipment contract negotiation installation and validation
Write operations manuals troubleshooting manuals continuous and preventive maintenance manuals
Analyze equipment to establish operating data and conduct experimental test and result analysis
Use engineering techniques to reduce product time to market whilst adhering to regulatory requirements project deadlines and product costs
Participate in process review meetings
Participate in process failure mode and effect analysis (PFMEA) control plan standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches
Complete capability studies for in-process inspection and generate subsequent inspection documentation
Conduct qualifications validations and measurement system analysis (MSA) studies for new products and new processes. Review and approve validation documentation
Workin a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development
Drive and execute effective communication with all stakeholders to enable project success
Provide training for manufacturing team members
Ensure adherence to GMP and safety procedures

What you need-

2 years of relevant work experience required
Bachelors degree in engineering required
Bachelors degree in Electrical Engineering highly preferred
Experience with programmable logic controllers (PLC) ladder logic and/or other similar programming languages highly preferred
Understanding of control system wiring and wiring diagrams highly preferred
Lean Six Sigma Green Belt Certification or above preferred
Knowledge of manufacturing processes materials product and process design preferred
Good understanding of design for manufacturing (DFM) related statistical tools and validation/verification techniques preferred
Experience writing and executing validations preferred
Experience in new product introduction or manufacturing engineering preferred
Experience in an FDA regulated or regulated industry preferred

Travel Percentage: 10%

Required Experience:

Senior IC

Key Skills

Distributed Control Systems
Continuous Improvement
Process Improvement
Minitab
Root cause Analysis
Tooling
Statistical Software
Process Engineering
cGMP
Programmable Logic Controllers
Public Speaking
Manufacturing

Apply Now

About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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