Product Development Engineer

Solesis•Apex, NC

About The Position

The Product Development Engineer aids in the development, validation, and commercialization of custom device components and assemblies, including ideation, prototyping, process optimization, qualification, and quality compliance. This role will partner with senior engineers to deliver Polyzen’s product development processes to meet customer needs. The Product Development Engineer will engage with key internal operational stakeholders and grow their business acumen by working with our business development teams, vendors, and clients.

Requirements

Bachelor’s degree in mechanical engineering, biomedical engineering, or related discipline.
One (1) to two (2) years of industry-related experience in a manufacturing or product development environment
Ability to learn manufacturing process development, qualifications, and capability assessments.
Familiar with ISO 9001, and 13485 Quality Management Standards; knowledge of FDA Regulations
Ability to understand the client’s needs, how the needs relate to project scopes, and how changes will affect other systems.
Ability to translate client inputs into engineering requirements based on technical skill set.
Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.
Excellent analytical, critical thinking, and problem-solving skills.
Excellent organization and decision-making skills.
Experience in technical writing and use of statistical tools, including Minitab.
Proficient with MS Excel, MS Word, MS Project, and MS PowerPoint.

Responsibilities

Support multiple projects for new product development in various stages of the product life cycle in line with agreed commitments to respective clients.
Communicate the status of development projects to internal stakeholders and leaders.
Assists in the design and manufacturing process to ensure scalability to a production environment based on customer design and volume requirements.
Aid in the identification of specific tooling, fixtures, and equipment for production purposes at the required scale and manufacturing throughput.
Partners with a cross-functional team to facilitate a transition of the manufacturing process from development groups to commercial groups while maintaining collaborative working relationships.
Responsible for documenting all development phases per the Polyzen product development process and quality compliance.
Compile, maintain, review, and interpret product development data.
Review SOPs, work instructions, batch records, product specifications, process performance qualification, and operational qualification protocol plans and reports critical to product development.
Supports senior engineers by providing technical input for early development programs and supports the Quality Assurance team with any non-conformance investigations.