Product Development Engineer II

About the position

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The Product Development Engineer II will participate in projects of varying scope and complexity across Integra with a focus on the neurological access devices. The Product Development Engineer II will be responsible for the mechanical design aspects of a project, interacting with external design and development partners, participating on cross-functional project teams through all phases of the product development process, and assisting the technical team with planning, executing, documenting and communicating testing activities.

Responsibilities

• Plan and conduct design/development engineering assignments generally involving parts of larger projects under a technical lead or independently leading smaller scope projects.
• Provide technical analysis regarding Mechanical Engineering aspects within project teams.
• Design new products/processes using appropriate software tools (e.g. SolidWorks or Onshape preferred).
• Provide support for field-based Sales Team and other Commercial partners.
• Partner with Upstream Marketing, Sales and key external stakeholders to identify unmet clinical/surgical needs, evaluate options and provide sound engineering solutions.
• Collaborate with internal and external partners to launch new products.
• Conduct feasibility studies of the design to determine ability to function as intended.
• Conduct design verification and validation studies.
• Create and manage engineering change requests and document change orders.
• Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
• Prepare cost and time estimates for engineering schedules.
• Provide extensive engineering documentation with proper use of Laboratory Notebooks and spreadsheet and graphical summary of results in support of development, intellectual property applications, regulatory FDA filing, and verification and validation protocols.
• Assure compliance with company Standard Operating Procedures and policies.
• Participate in team decision making.
• Design and implement new methodologies, materials, machines, processes or products.
• Prepare verbal presentations for various company meetings.

Requirements

• A B.S. or equivalent in a scientific discipline with 3 - 5 years of applied experience.
• A M.S. with 0-2 years of related applied experience or comparable applied experience in medical device, biotech or adjacent market segments.
• Experience managing projects is preferred.
• Medical device experience preferred.
• Experience working with electromechanical products, optical systems and/or electrical instrumentation is a plus.
• Demonstrated understanding of various types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T is required.
• The ability to work and execute project tasks within a cross functional environment is required.
• Prior experience working with project teams bringing products from concept to launch is preferred.
• Strong communication skills are required; the ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/or teams.
• Excellent written and verbal communication.