Sustaining Engineer
Company Name:
Stryker
Requidistion ID: 2850BR
Job Title: Sustaining Engineer
Group: Orthopaedics
Division: Orthobiologics
Business Function: Research and Development
Country: US
State/Province: PA
City: Malvern
Employment Category: FullTime
Percent Travel Required: 0
Shift 1st
About Stryker: Stryker is one of the world's leading medical technology companies and together with our customers, we are driven to make healthcare better.
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.
Stryker products and services are available in over 100 countries.
Job Description/Information:
The Sustaining Engineer will work closely with Quality Assurance and Global Quality and Operations (GQO) counterparts to support the CAPA and NCR project portfolio. Key elements of this role will be the facilitation and tracking of development initiatives to improve existing products, along with enhancing or creating new
procedures to prevent future issues. This role may also require leading complex, multifunctional teams to advance assigned projects through the design and development process.
The Sustaining Engineer will also support the development and introduction of new products and packaging and the sustainment and evolution of existing products and packaging. This role will identify, design, develop and commercialize innovative packaging and labeling solutions for Orthobiologics products
Specific responsibilities of the Sustaining Engineer include, but are not limited to, the following:
Support CAPA/NCR projects lead by QA and GQO
Modeling and detailing of implant, instrumentation, and packaging designs
Development of product and packaging/labeling prototypes for design verification and validation
Investigate new manufacturing technologies and materials for the packaging and labeling of orthopedic implants and instruments
Interfacing with clinical advisors and customers to gather input for design and evaluation of new
product
Utilization/Management of Design Controls (NPD)
Technical report writing as needed
Participation on cross functional design teams to develop new product as well as address design
issues/maintenance of existing ones
Learn all aspects of the surgical procedure in order to develop innovative solutions to solve and
satisfy customer needs
Develop and manage project plans and time lines within the scope of NPD guidelines
Establish and maintain relationships with the key design consulting groups in order to recognize
and anticipate industry trends and user needs
Minimum
Qualifications: Candidates should possess a minimum of a Bachelor's Degree.
Mechanical, Biomedical or Packaging Engineering is preferred.
Other required skills/experiences include the following:
2
years of product and package design experience in the medical device industry, or equivalent
Experience working with Quality systems
Experience leading complex product development initiatives from concept through release
Familiarity with design controls within a regulated industry
Demonstrated experience in a range of packaging/labeling processes; e.g.
design verification and
validation, operation of sealing equipment, label development and approval, etc.
Candidates should be self-starters, have a hands-on approach and capability to work independently
Experience with a parametric CAD design package
Project management experience preferred
Sustaining Engineer
PA-Malvern
2850BR Estimated Salary: $20 to $28 per hour based on qualifications.
Stryker
Requidistion ID: 2850BR
Job Title: Sustaining Engineer
Group: Orthopaedics
Division: Orthobiologics
Business Function: Research and Development
Country: US
State/Province: PA
City: Malvern
Employment Category: FullTime
Percent Travel Required: 0
Shift 1st
About Stryker: Stryker is one of the world's leading medical technology companies and together with our customers, we are driven to make healthcare better.
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.
Stryker products and services are available in over 100 countries.
Job Description/Information:
The Sustaining Engineer will work closely with Quality Assurance and Global Quality and Operations (GQO) counterparts to support the CAPA and NCR project portfolio. Key elements of this role will be the facilitation and tracking of development initiatives to improve existing products, along with enhancing or creating new
procedures to prevent future issues. This role may also require leading complex, multifunctional teams to advance assigned projects through the design and development process.
The Sustaining Engineer will also support the development and introduction of new products and packaging and the sustainment and evolution of existing products and packaging. This role will identify, design, develop and commercialize innovative packaging and labeling solutions for Orthobiologics products
Specific responsibilities of the Sustaining Engineer include, but are not limited to, the following:
Support CAPA/NCR projects lead by QA and GQO
Modeling and detailing of implant, instrumentation, and packaging designs
Development of product and packaging/labeling prototypes for design verification and validation
Investigate new manufacturing technologies and materials for the packaging and labeling of orthopedic implants and instruments
Interfacing with clinical advisors and customers to gather input for design and evaluation of new
product
Utilization/Management of Design Controls (NPD)
Technical report writing as needed
Participation on cross functional design teams to develop new product as well as address design
issues/maintenance of existing ones
Learn all aspects of the surgical procedure in order to develop innovative solutions to solve and
satisfy customer needs
Develop and manage project plans and time lines within the scope of NPD guidelines
Establish and maintain relationships with the key design consulting groups in order to recognize
and anticipate industry trends and user needs
Minimum
Qualifications: Candidates should possess a minimum of a Bachelor's Degree.
Mechanical, Biomedical or Packaging Engineering is preferred.
Other required skills/experiences include the following:
2
years of product and package design experience in the medical device industry, or equivalent
Experience working with Quality systems
Experience leading complex product development initiatives from concept through release
Familiarity with design controls within a regulated industry
Demonstrated experience in a range of packaging/labeling processes; e.g.
design verification and
validation, operation of sealing equipment, label development and approval, etc.
Candidates should be self-starters, have a hands-on approach and capability to work independently
Experience with a parametric CAD design package
Project management experience preferred
Sustaining Engineer
PA-Malvern
2850BR Estimated Salary: $20 to $28 per hour based on qualifications.
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