Sr Product Development Engineer - Active Implantables

Description

Job Summary

This position will design and develop new active implantable products and/or modify existing products and participate in the execution of development projects as part of a multi-functional project team, with an emphasis on leads development.

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. Design and develop innovative products, incorporating Design for Manufacturability and Assembly principles, managing the product design from concept to full production.

This position will lead in the technical execution of development projects as part of a multi-functional project team.

Essential Functions

• Design and implement new products based on customer specifications
• Develop product requirement specifications based on customer needs and applicable guidelines (industrial and government guidelines and/or standards)
• Understanding the end use of products, determining fitness-for-use of materials, and effectively advancing the specification development of new and derivative products
• Specify and develop tests for product testing determining acceptability of designs to requirements
• Perform data analysis (statistical and practical) and develop appropriate action plans based upon such analysis
• Develop tooling and test equipment designs for product assembly and testing
• Prepare plans and schedules for own work
• 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
• Serve as Technical leader, and cross-functional team member representing Product Development, for development projects (as assigned). Duties include task management, organize and facilitation technical team meetings, leading technical reviews, documentation, and coordination of project activities
• Support new production processes and launches to ensure product is manufactured according to design, safety, and quality specifications
• Communicate progress and decisions to associates and functional manager
• Support Internal & External (customer) functions of finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
  
  

Functional Knowledge

• Familiarity with good engineering techniques
• Familiarity with human anatomy preferred
• Articulate and able to effectively communicate very technical subjects with peers and customers
• Knowledge of machining and assembly practices, tools and fixturing (plastic and/or metal preferred)
  
  

Requirements

Education, Experience, Required Skills

• Ability to handle and be trusted with confidential and/or sensitive information
• Bachelor’s degree in engineering (equivalent work experience may be considered)
• 5 years of experience in medical device industry with focus in Product Development of neuro/cardiac leads or active implantable devices.
• Exposure to development or manufacturing of full active implantable systems preferred.
• Strong problem-solving skills to identify, gather, and analyze information develop solutions, work under pressure, and resolve problems in a timely manner
• 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
• Able to work in a fast-paced, constantly changing environment
• Ability to work overtime if needed
• Ability to travel to support projects and customer 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
  
  

Summary 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 Holidays
• 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 $105,000-125,000/year. Compensation will vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
• 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.