Solesis ยท 14 hours ago
Product Development Engineer
Apex, North Carolina, United States
Full-time
Onsite
Entry Level
1+ years expPolyzen is a leading developer and manufacturer of customized polymer-based materials for the medical device industry. The Product Development Engineer will aid in the development, validation, and commercialization of custom device components and assemblies, collaborating with senior engineers and internal stakeholders to meet customer needs.
Health CareManufacturing
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
Qualification
Required
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
Benefits
Generous Paid Time Off
Paid Breaks
Annual Bonuses
401k with excellent company match
Health Insurance with multiple plans to choose form
Paid Short Term and Long Term Disability
Company
Solesis
Solesis is an innovative provider of biomaterials solutions and services primarily focused on the MedTech and Biopharma industries.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2021-04-15Acquired
Leadership Team
John Witkowski
President and CEO
Recent News
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