Job Description

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

Functional Knowledge

• 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

Education, Experience, Required Skills

• 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

Physical 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

Authority and Responsibility

• Accountable for their performance and will have authority as delegated to complete their tasks and objectives

of 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
• Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

• The typical base pay range for this role is between $105,000-135,000/year. Compensation varies based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for an annual incentive program driven by organization and individual performance.
• 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.