Product Development Engineer

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, part of the Solesis family of companies, develops and manufactures customized polymer-based materials, including extruded and molded components, and device assemblies that help innovators turn bold ideas into lasting breakthroughs. Operating in Apex, North Carolina, USA, Polyzen employs more than 75 team members.

Guided by a commitment to innovation, quality and customer success, Polyzen collaborates with customers to solve complex polymer challenges and bring new technologies from concept to commercialization. Employees play a vital role in advancing solutions that enable innovation and positively impact lives around the world.

1st shift Monday-Friday 8:00 am-5:00 pm

About the role:

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.

What you will do:

• 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.

Who you are:

• 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.
• Generous Paid Time Off
• Annual Bonus
• 401(K) with excellent company match
• Health Insurance with multiple plans to choose form
• Paid Short Term and Long Term Disability

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.