mechanical Engineer - R&D Engineer IV - Talent Software Services, Inc.
Maple Grove, MN 55311
About the Job
Job Description: Job Purpose
Independently conducts root cause investigation, design solution identification, and design solution implementation work as part of a major research and/or development project. Receives minimal technical direction/review on broad scope or complex projects.
Key Responsibilities
" Solve engineering problems by analyzing the situation and recommending corrective or alternative actions.
" Lead the design & execution of structured experimental plans to drive data-based decisions.
" Create and update drawings, BOM's, and other design outputs.
" Support Design Change Assessments (DCA's) for Capital Equipment.
" Develop and update test methods for evaluating product requirements and design specifications.
" Write and execute protocols/reports for Design Verification.
" Provide clear communication to stakeholders.
" Leverage internal/external partners to achieve project objectives.
" Work cooperatively with Process Development, Quality, Manufacturing, Regulatory, Clinical, and Marketing on complex projects to ensure project success.
" Create a strong team culture around high expectations & high performance.
" In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to all documented quality processes and procedures.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Minimum Qualifications:
" Bachelor's degree in mechanical, Biomedical, or similar Engineering.
" Bachelor's Degree with 6+ years, OR Master's Degree with 5 years or more experience.
" Strong mechanical engineering skills, specifically with machined, sheet metal and injection molded component design for manufacturability and assembly.
" Solid medical device or regulated industry design control process and documentation experience (i.e. Windchill).
" Excellent organizational, communication, and collaboration skills.
" 2 years' experience with SolidWorks or similar CAD software.
" Must be a "self-starter and willing to reach out to cross-functional team members.
Preferred Qualifications:
" Expertise in design simulation tools and analysis techniques.
" Experience with working with external vendors.
" Experience with tolerance stack-up and thermal analysis.
" Experience with reliability and HALT testing.
" IEC 60601-1 (Product Safety) experience with Medical Devices.
Independently conducts root cause investigation, design solution identification, and design solution implementation work as part of a major research and/or development project. Receives minimal technical direction/review on broad scope or complex projects.
Key Responsibilities
" Solve engineering problems by analyzing the situation and recommending corrective or alternative actions.
" Lead the design & execution of structured experimental plans to drive data-based decisions.
" Create and update drawings, BOM's, and other design outputs.
" Support Design Change Assessments (DCA's) for Capital Equipment.
" Develop and update test methods for evaluating product requirements and design specifications.
" Write and execute protocols/reports for Design Verification.
" Provide clear communication to stakeholders.
" Leverage internal/external partners to achieve project objectives.
" Work cooperatively with Process Development, Quality, Manufacturing, Regulatory, Clinical, and Marketing on complex projects to ensure project success.
" Create a strong team culture around high expectations & high performance.
" In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to all documented quality processes and procedures.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Minimum Qualifications:
" Bachelor's degree in mechanical, Biomedical, or similar Engineering.
" Bachelor's Degree with 6+ years, OR Master's Degree with 5 years or more experience.
" Strong mechanical engineering skills, specifically with machined, sheet metal and injection molded component design for manufacturability and assembly.
" Solid medical device or regulated industry design control process and documentation experience (i.e. Windchill).
" Excellent organizational, communication, and collaboration skills.
" 2 years' experience with SolidWorks or similar CAD software.
" Must be a "self-starter and willing to reach out to cross-functional team members.
Preferred Qualifications:
" Expertise in design simulation tools and analysis techniques.
" Experience with working with external vendors.
" Experience with tolerance stack-up and thermal analysis.
" Experience with reliability and HALT testing.
" IEC 60601-1 (Product Safety) experience with Medical Devices.
Source : Talent Software Services, Inc.