Product Development Engineer: Prototyping & Generous PTO

Polyzen, Inc.; Apex (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Generous Paid Time Off

Annual Bonus

401(K) with company match

Health Insurance

Paid Short Term Disability

Paid Long Term Disability

Job summary

Polyzen, Inc. in Apex, NC seeks a Product Development Engineer to support development, validation, and commercialization of custom device components and assemblies.

You will ideate, prototype, optimize processes, ensure quality compliance, and partner with senior engineers and cross-functional teams to meet customer needs. Successful candidates have a BS in a related engineering field, 1–2 years of manufacturing or product development experience, and familiarity with ISO 9001/13485 and FDA

Qualifications

• Bachelor’s degree in mechanical or biomedical engineering or related field.
• 1–2 years of industry experience in manufacturing or product development.
• Familiar with ISO 9001, ISO 13485; knowledge of FDA regulations.
• Ability to translate client needs into engineering requirements.

Responsibilities

• Support multiple development projects across stages of product life cycle.
• Communicate project status to internal stakeholders and leaders.
• Assist in design and manufacturing to scale for production.
• Aid in tooling, fixtures, and equipment selection for production.
• Collaborate across functions to transition development to production.
• Document all development phases per processes and quality standards.
• Review SOPs, batch records, and qualification protocols.
• Provide technical input to senior engineers and assist QA with investigations.

Skills

Teamwork

Analytical thinking

Problem-solving

Organization

Technical writing

Communication

Education

Bachelor’s degree in mechanical engineering, biomedical engineering, or related discipline

Tools

MS Excel

MS Word

MS Project

MS PowerPoint

Minitab

Job description

Polyzen, Inc. in Apex, NC seeks a Product Development Engineer to support development, validation, and commercialization of custom device components and assemblies.

You will ideate, prototype, optimize processes, ensure quality compliance, and partner with senior engineers and cross-functional teams to meet customer needs. Successful candidates have a BS in a related engineering field, 1–2 years of manufacturing or product development experience, and familiarity with ISO 9001/13485 and FDA