Position Details

SR. PRODUCT DEVELOPMENT ENGINEER

Sr. Product Development Engineer
Full Time Direct Hire
Salary is DOE (target is ~105-120k)
Harrisburg, NC 28075; ~15% Travel (Nationally and Internationally)
Relocation Assistance is available
Available for long term employment with no Visa Sponsorship at any point

Summary
The Senior Product Development Engineer is responsible for designing and developing medical device product(s) including concept development, requirements generation, prototype fabrication, assembly and component design, and generation of engineering documentation. Also responsible for testing finished product for quality purposes and recommend changes to product specifications, as necessary. Will use a wide degree of creativity and latitude to accomplish varied and complicated tasks relying on experience and judgement to plan and accomplish goals. May act as the project lead for cross-functional teams with minimal supervision.

Required Skills / Experience:
• Minimum of 5 years experience in the medical device field
• Medical Device Design and Development
• FDA CFR and ISO Standards
• Experience in 3D modeling and drafting required; Solid Works software experience preferred.
• Project Management and/or Team Lead experience
• Bachelor’s degree in engineering

Desired:
• MiniTab
• Experience with sterilization and packaging validation activities

Soft Skills:
Demonstrates ownership and accountability, ability to be self-directed, to plan, execute, control, and deliver on project tasks and overall goals. Possesses strong written and verbal communication skills, team-oriented personality with the ability to lead and influence others effectively while creating and maintaining a positive environment. Ability to develop and maintain relationships with medical professionals, sales force, and cross functional team members. Understanding of change management, conflict resolution and team dynamics. Excellent problem-solving skills, including experience implementing the DMAIC thought process and structured root cause analysis. Ability to identify project and design risks and create mitigation strategies. Ability to independently make sound decisions with available information. Ability to analyze data using statistical methods.

Responsibilities:
• Performs the design, development, implementation, and analysis of systems, products, assemblies, and components that meet specified requirements.
• Acts as a lead of projects in the definition, planning, and requirements generation of new or updated products.
• Delivers on-time, on-quality, and on-budget project tasks.
• Performs engineering qualification, verification, and validation testing for new and updated components and assemblies.
• Complies with all SOP and regulatory requirements pertaining to the development of medical device (per FDA 21 CFR part 820 and ISO 13485).
• Utilizes CAD or equivalent to create and modify 3D components and assemblies and their associated drawings per industry standards.
• Develops and maintains product and/or process documentation (such as specification documents, Bill of Materials, Design History Files, Engineering Change Orders, etc.).
• Assists with outside manufacturer selection, evaluation, and communication and provides support in the establishment and maintenance of suppliers.
• Manage and prioritize daily tasks/work of Product Engineers, Engineering Designers and/or Engineering Technicians on the project team.
• Identify and mitigate project or design risks throughout the project plan.
• Effectively manage work for up to three new product development projects simultaneously.
• Respect for people with a desire to develop junior-level team members including coaching in 1:1 and team settings.

Benefits:
• Medical, Dental & Vision
• Life insurance, AD&D, and Disability
• 401k


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