Senior Engineer- Design Quality

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

What you will do:

Reviewquality assurance documentation to support mainlyproduct sustenance and regulatory submissions or new product development related to line extensions/custom made devices and product life cycle management.
Support quality system maintenance and effectiveness by identifying and correcting deficiencies in procedures and practices.
Execute risk management activities for NPI and Sustenance projects - Ensure that risk assessments are conducted in accordance with EUMDR requirements.
Participate in design reviews by identifying risks associated with the product used and tracking how the design documentation and manufacturing process mitigate those issues throughout the development or legacy careprocess.
Taking care of timely and quality deliverables for assigned projects.
Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
Work closely with R&D Clinical Affairs Post Market and other departments to integrate EUMDR compliance into product development processes.

What you need:

Required Skills:

in Mechanical Engineering / Biomedical. Experience: 3-6 years
2 years experience in Design Quality Assurance (medical devices) or new product development
In-depth knowledge of EUMDR requirements and other relevant regulations. Relevant certifications in regulatory affairs or quality management may be beneficial.
Excellent understanding of Quality Management Systems. (ISO 13485 21 CRF 820).Prefer experience with medical device product development lifecycle including risk management and design/process verification and validation.
Knowledge of EU MDR changes ISO 14971 IEC 62366 Quality Concepts (e.g. CAPA Audits Statistics).

Preferred Skills:

AQE should drive coordination with different departments (such a R&D Post Market Regulatory Clinical) to ensure the resulting part/product/process is safe compliant and effective.
Demonstrated ability to advocate for product excellence and quality.
Strong experience in establishing world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
Educate the organization in exceptional engineering processes & practices; including good documentation formal design reviews and the other practices mentioned detailed job description here.

Travel Percentage: 20%

Required Experience:

Senior IC

Work Flexibility: HybridWhat you will do:Reviewquality assurance documentation to support mainlyproduct sustenance and regulatory submissions or new product development related to line extensions/custom made devices and product life cycle management.Support quality system maintenance and effectivene...

Work Flexibility: Hybrid

What you will do:

Reviewquality assurance documentation to support mainlyproduct sustenance and regulatory submissions or new product development related to line extensions/custom made devices and product life cycle management.
Support quality system maintenance and effectiveness by identifying and correcting deficiencies in procedures and practices.
Execute risk management activities for NPI and Sustenance projects - Ensure that risk assessments are conducted in accordance with EUMDR requirements.
Participate in design reviews by identifying risks associated with the product used and tracking how the design documentation and manufacturing process mitigate those issues throughout the development or legacy careprocess.
Taking care of timely and quality deliverables for assigned projects.
Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
Work closely with R&D Clinical Affairs Post Market and other departments to integrate EUMDR compliance into product development processes.

What you need:

Required Skills:

in Mechanical Engineering / Biomedical. Experience: 3-6 years
2 years experience in Design Quality Assurance (medical devices) or new product development
In-depth knowledge of EUMDR requirements and other relevant regulations. Relevant certifications in regulatory affairs or quality management may be beneficial.
Excellent understanding of Quality Management Systems. (ISO 13485 21 CRF 820).Prefer experience with medical device product development lifecycle including risk management and design/process verification and validation.
Knowledge of EU MDR changes ISO 14971 IEC 62366 Quality Concepts (e.g. CAPA Audits Statistics).

Preferred Skills:

AQE should drive coordination with different departments (such a R&D Post Market Regulatory Clinical) to ensure the resulting part/product/process is safe compliant and effective.
Demonstrated ability to advocate for product excellence and quality.
Strong experience in establishing world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
Educate the organization in exceptional engineering processes & practices; including good documentation formal design reviews and the other practices mentioned detailed job description here.

Travel Percentage: 20%

Required Experience:

Senior IC

Key Skills

Electrical Engineering
SOC
PCB
Warehouse Management
Warehouse Experience
CAD
Creo
SolidWorks
Data Mining
Digital design
Mechanical Engineering
Autocad

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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Senior Engineer- Design Quality

Bengaluru - India

Job Summary

What you will do:

Reviewquality assurance documentation to support mainlyproduct sustenance and regulatory submissions or new product development related to line extensions/custom made devices and product life cycle management.

Support quality system maintenance and effectiveness by identifying and correcting deficiencies in procedures and practices.

Execute risk management activities for NPI and Sustenance projects - Ensure that risk assessments are conducted in accordance with EUMDR requirements.

Participate in design reviews by identifying risks associated with the product used and tracking how the design documentation and manufacturing process mitigate those issues throughout the development or legacy careprocess.

Taking care of timely and quality deliverables for assigned projects.

Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.

Work closely with R&D Clinical Affairs Post Market and other departments to integrate EUMDR compliance into product development processes.

What you need:

Required Skills:

in Mechanical Engineering / Biomedical. Experience: 3-6 years

2 years experience in Design Quality Assurance (medical devices) or new product development

In-depth knowledge of EUMDR requirements and other relevant regulations. Relevant certifications in regulatory affairs or quality management may be beneficial.

Excellent understanding of Quality Management Systems. (ISO 13485 21 CRF 820).Prefer experience with medical device product development lifecycle including risk management and design/process verification and validation.

Knowledge of EU MDR changes ISO 14971 IEC 62366 Quality Concepts (e.g. CAPA Audits Statistics).

Preferred Skills:

AQE should drive coordination with different departments (such a R&D Post Market Regulatory Clinical) to ensure the resulting part/product/process is safe compliant and effective.

Demonstrated ability to advocate for product excellence and quality.

Strong experience in establishing world class risk methodologies for complex systems based upon existing corporate/divisional approaches.

Educate the organization in exceptional engineering processes & practices; including good documentation formal design reviews and the other practices mentioned detailed job description here.

What you will do:

Reviewquality assurance documentation to support mainlyproduct sustenance and regulatory submissions or new product development related to line extensions/custom made devices and product life cycle management.

Support quality system maintenance and effectiveness by identifying and correcting deficiencies in procedures and practices.

Execute risk management activities for NPI and Sustenance projects - Ensure that risk assessments are conducted in accordance with EUMDR requirements.

Participate in design reviews by identifying risks associated with the product used and tracking how the design documentation and manufacturing process mitigate those issues throughout the development or legacy careprocess.

Taking care of timely and quality deliverables for assigned projects.

Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.

Work closely with R&D Clinical Affairs Post Market and other departments to integrate EUMDR compliance into product development processes.

What you need:

Required Skills:

in Mechanical Engineering / Biomedical. Experience: 3-6 years

2 years experience in Design Quality Assurance (medical devices) or new product development

In-depth knowledge of EUMDR requirements and other relevant regulations. Relevant certifications in regulatory affairs or quality management may be beneficial.

Excellent understanding of Quality Management Systems. (ISO 13485 21 CRF 820).Prefer experience with medical device product development lifecycle including risk management and design/process verification and validation.

Knowledge of EU MDR changes ISO 14971 IEC 62366 Quality Concepts (e.g. CAPA Audits Statistics).

Preferred Skills:

AQE should drive coordination with different departments (such a R&D Post Market Regulatory Clinical) to ensure the resulting part/product/process is safe compliant and effective.

Demonstrated ability to advocate for product excellence and quality.

Strong experience in establishing world class risk methodologies for complex systems based upon existing corporate/divisional approaches.

Educate the organization in exceptional engineering processes & practices; including good documentation formal design reviews and the other practices mentioned detailed job description here.

Key Skills

About Company

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