Sr R/D Engineer
Apply NowCompany: ATR International
Location: Irvine, CA 92620
Description:
The 3 main responsibilities/day to day activities required for this role:
1.Review and analyze current testing and confirm if additional testing is needed.
2.Generate testing data to support testing strategy.
3.develop and validate test methods used to generate test data.
Responsibilities may include the following and other duties may be assigned.
Understands the requirements of cross-functional internal customers.
Understanding and wide application of technical principles, theories and concepts in the field.
Participates in preclinical evaluations.
Responsible for subset of product design.
Develops product specs, test methods, equipment Execute tolerance analysis.
Creates, reviews and approves protocols/reports.
Interprets test results.
Working knowledge of DRM and statistics.
Responsible for subsystems of designs or smaller designs in their entirety.
Completes tasks associated with area of responsibility within assigned schedule.
Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA's, contributes to assigned sections of submission documents.
4.Possible: Review of technical specifications and requirement documents
5.Possible: Modify current design to align to newer product technology/requirements
6.Possible: Translate new requirements to supplier
2.What products (if any) will this role support? This will be supporting our NPD program PELE while possibly being a resource on other initiatives.
Responsibilities may include the following and other duties may be assigned Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development Designs studies to investigate specific life science questions within field of expertise May be involved in product research and development and/or clinical trials Translates research discoveries into usable and marketable products SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results May act as a mentor to colleagues or may direct the work of other lower level professionals The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University) DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor Works independently under limited supervision to determine and develop approach to solutions Coaches and reviews the work of lower level specialists may manage projects / processes Organizational Impact: May be responsible for entire projects or processes within job area Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties Makes improvements of processes, systems or products to enhance performance of the job area Analysis provided is indepth in nature and often provides recommendations on process improvements Communication and Influence: Communicates with senior internal and external customers and vendors Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area May manage projects, requiring delegation of work and review of others' work product
Requirement:
Top 3 skills sets required:
-Phase 2 & Phase 3 test development and testing.
-characterization protocol generation and testing
-design verification protocol generation and testing
-test method development and validation
-fixture development
-Analysis of technical specifications and requirements.
-Design modification - translations into/ to specifications/requirements
-Testing/qualification of new components
Target years of experience: 8-10 years - need someone that is independent and has enough experience
Working knowledge of internal quality system (e.g SOPs, DOPs), external quality standards, and statistical methods.
Design characterization and design selection experience
Nice to Have (Preferred Qualifications)
Experience with medical device-based products, processes, and technologies
Medical Device/Pharmaceutical or other regulated industry experience
Design characterization and design selection experience
Experience with SolidWorks or AutoCAD
Proven experience executing product changes regulated by design control, applying product development process to derivative product line
Mechanical design experience - modeling for devices and fixtures
Prototyping of devices and fixtures through 3d printing and/or machining catheter device experience
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience May have practical knowledge of project management Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Benefits:
Benefits include:
-MEC/ACP Medical
-Voluntary Dental, Vision, Life, Supplemental Income
-401k (must meet requirements)
-sick leave as required by state/county
1.Review and analyze current testing and confirm if additional testing is needed.
2.Generate testing data to support testing strategy.
3.develop and validate test methods used to generate test data.
Responsibilities may include the following and other duties may be assigned.
Understands the requirements of cross-functional internal customers.
Understanding and wide application of technical principles, theories and concepts in the field.
Participates in preclinical evaluations.
Responsible for subset of product design.
Develops product specs, test methods, equipment Execute tolerance analysis.
Creates, reviews and approves protocols/reports.
Interprets test results.
Working knowledge of DRM and statistics.
Responsible for subsystems of designs or smaller designs in their entirety.
Completes tasks associated with area of responsibility within assigned schedule.
Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA's, contributes to assigned sections of submission documents.
4.Possible: Review of technical specifications and requirement documents
5.Possible: Modify current design to align to newer product technology/requirements
6.Possible: Translate new requirements to supplier
2.What products (if any) will this role support? This will be supporting our NPD program PELE while possibly being a resource on other initiatives.
Responsibilities may include the following and other duties may be assigned Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development Designs studies to investigate specific life science questions within field of expertise May be involved in product research and development and/or clinical trials Translates research discoveries into usable and marketable products SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results May act as a mentor to colleagues or may direct the work of other lower level professionals The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University) DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor Works independently under limited supervision to determine and develop approach to solutions Coaches and reviews the work of lower level specialists may manage projects / processes Organizational Impact: May be responsible for entire projects or processes within job area Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties Makes improvements of processes, systems or products to enhance performance of the job area Analysis provided is indepth in nature and often provides recommendations on process improvements Communication and Influence: Communicates with senior internal and external customers and vendors Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area May manage projects, requiring delegation of work and review of others' work product
Requirement:
Top 3 skills sets required:
-Phase 2 & Phase 3 test development and testing.
-characterization protocol generation and testing
-design verification protocol generation and testing
-test method development and validation
-fixture development
-Analysis of technical specifications and requirements.
-Design modification - translations into/ to specifications/requirements
-Testing/qualification of new components
Target years of experience: 8-10 years - need someone that is independent and has enough experience
Working knowledge of internal quality system (e.g SOPs, DOPs), external quality standards, and statistical methods.
Design characterization and design selection experience
Nice to Have (Preferred Qualifications)
Experience with medical device-based products, processes, and technologies
Medical Device/Pharmaceutical or other regulated industry experience
Design characterization and design selection experience
Experience with SolidWorks or AutoCAD
Proven experience executing product changes regulated by design control, applying product development process to derivative product line
Mechanical design experience - modeling for devices and fixtures
Prototyping of devices and fixtures through 3d printing and/or machining catheter device experience
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience May have practical knowledge of project management Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Benefits:
Benefits include:
-MEC/ACP Medical
-Voluntary Dental, Vision, Life, Supplemental Income
-401k (must meet requirements)
-sick leave as required by state/county