Senior Process Engineer, Advanced Operations

Stryker Corporation; Portage (MI); On-site; USD 78,000 - 130,000; Full time

Job summary

Stryker Corporation in Portage, MI is seeking a Senior Engineer, Process Development to lead new product and process introductions on an onsite basis. You will ensure process and product quality, select components and equipment, and collaborate with QA to develop testing protocols.

The role requires a bachelor’s degree in engineering, 2+ years experience, PFMEA and GD&T proficiency, CAD skills, and the ability to read complex drawings.

Qualifications

• Bachelor’s degree in engineering required.
• 2+ years of applicable full-time work experience required.
• Working knowledge of PFMEA required.
• Ability to read and interpret complex engineering drawings and GD&T required.
• CAD experience required.

Responsibilities

• 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.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Select components and equipment based on analysis of specifications, reliability and regulatory requirements.
• Work with quality engineers to develop component specific testing and inspection protocols.
• Lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
• Analyze equipment to establish operating data, conduct experimental test and result analysis.
• Lead and/or participate in process review meetings.
• Participate in Process Failure Mode and Effect Analysis, Control Plan, SOP and Production Part Approval Process generation associated with product transfers and launches.
• Complete capability studies for in process inspection and generate subsequent Inspection documentation.
• Conduct MSA studies for new products and new processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Review and approval of validation documentation.

Skills

Analytical skills

Planning & organizing

Reading drawings

GD&T knowledge

Education

Bachelor’s degree in engineering

Tools

PFMEA

CAD

Job description

Work Flexibility: Onsite Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.

We are currently seeking a Senior Engineer, Process Development to join our OrthoTech Division. This is an onsite position in Portage, MI.

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.
• Ensure quality of process and product as defined in the appropriate operation and material specifications.
• Select components and equipment based on analysis of specifications, reliability and regulatory requirements.
• Work with quality engineers to develop component specific testing and inspection protocols.
• Lead/support capital acquisition activity from specifying equipment, contract negotiation, Installation and validation.
• Analyze equipment to establish operating data, conduct experimental test and result analysis.
• Lead and/or participate in process review meetings.
• Participate in Process Failure Mode and Effect Analysis, Control Plan, SOP and Production Part Approval Process generation associated with product transfers and launches.
• Complete capability studies for in process inspection and generate subsequent Inspection documentation.
• Conduct MSA studies for new products and new processes.
• Provide training for manufacturing team members.
• Ensure adherence to GMP and safety procedures.
• Review and approval of validation documentation.

What you need:

• Bachelor’s degree in engineering required
• 2+ years of applicable full-time work experience required
• Working knowledge of PFMEA required
• Excellent analytical skills, ability to plan, organize, and implement concurrent tasks required
• Good knowledge of manufacturing processes, materials, product and process design required
• Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing (GD&T) required
• CAD experience

$77,700 - $129,500 USD Annual Travel Percentage: 10%

Work Flexibility

Remote

Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based

You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite

Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements.

Hybrid

You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

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 contractor’s legal duty to furnish information. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com