Sr Product Development Engineer - Test Method Development

RESOLUTION MEDICAL LLC • Minneapolis, MN

2d • $105,000 - $135,000

About The Position

Job Summary
Activities include product design and development, defining technical solutions to abstract problems, defining methods and processes, design modeling, tooling design/fabrication, equipment design/fabrication, personnel management, design verification and validation, and documentation. Manage the day-to-day execution of reliability tasks by teams and team members through monitoring progress, providing technical direction, and problem-solving solutions. Subject matter expert on test method development and design verification. Primarily by driving the testing of device, assist in design and develop innovative products & manage the product design from concept to full production.
This position will lead in the execution of development projects as part of a multi-functional project team with an emphasis on the V&V activities.

Essential Functions
Product Development (~50% allocation):
Research, design and implement new products based on customer specifications
Understand the end use of products, determine fitness-for-use of materials, and effectively advancing the specification development of new and derivative products
Perform data analysis (statistical and practical) and develop appropriate action plans based upon such analysis
Prepare and present plans and schedules as Technical Project Lead
Serve as Technical leader, and cross-functional team member representing Product Development, for development projects (as assigned). Duties include task management, organize and facilitate technical team meetings, lead technical reviews, provide documentation and coordinate project activities
Perform as a technical resource to all departments with a thorough understanding of related disciplines
Communicate progress and decisions to customers, associates and functional managers
Assist management in improving systems for product development, standard operating procedures, safety, quality control and training
Identify opportunities for productivity and quality improvements
Perform product/process analysis for cost reduction, quality improvement, and improved efficiency
Perform research, design and development of product assembly methods including production equipment
Contribute to the development of project plans that meet the required customer and/or internal milestones, specifications, and product cost goals, within project budget and staff assignments
Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
Follow company policies and procedures
Requirements, Verification, & Testing (~50% allocation)
Design and develop simulated use models for engineering confidence testing and DVT. Specify and develop tests for product testing determining acceptability of designs to requirements
Develop product requirement specifications based on customer needs and applicable guidelines (industrial and government guidelines and/or standards)
Strong preference for experience in common catheter standards (e.g. ISO10555) or common active implantable device standards (e.g. ISO14708)
Develop tooling and test equipment designs for product assembly and testing

Requirements

• Good engineering techniques
• Knowledge of human anatomy
• Articulate and able to effectively communicate very technical subjects with peers and customers
• Knowledge of machining and assembly practices, tools and fixturing is required. Knowledge of plastic and/or metal is preferred
• Bachelor’s degree in related field (equivalent work experience may be considered)
• Five (5) + years of medical device industry experience as an individual contributor with a majority of time spent on requirements development, design verification, & test method development.
• Strong strategic focus in the areas of Product and Process Development
• Ability to handle and be trusted with confidential and/or sensitive information
• Strong problem-solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner
• Must have knowledge of machining and assembly practices, tools and fixturing (plastic and/or metal preferred)
• Proficiency in 3D CAD Software (preferably SolidWorks) In addition to fixture design, must be able to open, view and manipulate assemblies
• Demonstrated ability to implement change, in a way that positively impacts overall department and company performance
• Must be able to handle multiple projects simultaneously
• Must excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross functionally drive results
• Excellent written and verbal communication skills
• Able to work in a fast-paced, constantly changing environment
• Ability to be flexible and to handle multiple projects in an organized, timely manner
• Able to problem-solve, work under pressure, and to effectively manage stress
• Ability to work overtime if needed
• Ability to travel to support projects and customer requirements
• Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 25 pounds at times
• Must wear gown, gloves, ear protection and other personal protective equipment when applicable

Nice To Haves

• Strong preference for experience in common catheter standards (e.g. ISO10555) or common active implantable device standards (e.g. ISO14708)

Responsibilities

• Research, design and implement new products based on customer specifications
• Understand the end use of products, determine fitness-for-use of materials, and effectively advancing the specification development of new and derivative products
• Perform data analysis (statistical and practical) and develop appropriate action plans based upon such analysis
• Prepare and present plans and schedules as Technical Project Lead
• Serve as Technical leader, and cross-functional team member representing Product Development, for development projects (as assigned). Duties include task management, organize and facilitate technical team meetings, lead technical reviews, provide documentation and coordinate project activities
• Perform as a technical resource to all departments with a thorough understanding of related disciplines
• Communicate progress and decisions to customers, associates and functional managers
• Assist management in improving systems for product development, standard operating procedures, safety, quality control and training
• Identify opportunities for productivity and quality improvements
• Perform product/process analysis for cost reduction, quality improvement, and improved efficiency
• Perform research, design and development of product assembly methods including production equipment
• Contribute to the development of project plans that meet the required customer and/or internal milestones, specifications, and product cost goals, within project budget and staff assignments
• Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
• Follow company policies and procedures
• Design and develop simulated use models for engineering confidence testing and DVT. Specify and develop tests for product testing determining acceptability of designs to requirements
• Develop product requirement specifications based on customer needs and applicable guidelines (industrial and government guidelines and/or standards)
• Develop tooling and test equipment designs for product assembly and testing

Benefits

• Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
• Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
• Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
• Flexible Time Off Program
• Paid Parental Leave
• Paid Holidays
• Company-provided Safe Harbor Contribution of 3% of eligible earnings.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level