Engineer 2 - NPI Electro-Mechanical

$82,000 - $102,500/Yr

Terumo BCT - Lakewood, CO

Full-time - Mid Level

Lakewood, CO

5,001-10,000 employees

Miscellaneous Manufacturing

About the position

The Engineer 2 - NPI Electro-Mechanical position at Terumo Blood and Cell Technologies involves supporting the manufacturing launch of new and revised electro-mechanical medical devices. The role is focused on engineering execution for assigned projects, collaborating with various functional business groups to ensure successful design transfer to manufacturing. The engineer will be responsible for research, design, and development of manufacturing processes, ensuring product quality, and preparing technical documentation.

Responsibilities

• Supports the manufacturing launch of new/revised products.
• Performs research, design, and development of manufacturing processes including production flow, assembly methods, and production test equipment.
• Designs, implements, and validates high performing processes that assure product quality.
• Partners with Design Team to understand product requirements and supports Design for Manufacturability initiatives.
• Prepares and reviews engineering/technical documents such as reports, SOPs, protocols, MOPs, and validation documentation.
• May provide work direction to production assemblers during design transfer activities.
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives, and recommending solutions.
• Follows department processes and regularly makes recommendations on these processes.
• Follows technical specification requirements, developing reports, charts, and graphs to support project recommendations and responds to questions from technical staff members and management.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• May work with other manufacturing sites, including CMOs.

Requirements

• Bachelors degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelors of Science degree in Engineering preferred.
• Minimum 2 years experience.
• 2 years of related working experience in HLA/System integration preferred.
• Understands manufacturing and test equipment concepts, technologies, and techniques and how to apply them to improve quality and efficiency.
• Experience with Solidworks and Minitab preferred.
• Requires interactive skills in cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team members including global manufacturing teams.
• Mechanical and electronic ability and aptitude to assist with equipment trouble-shooting.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues and train and provide work direction to operators and production service technicians.
• Understanding of and adherence to GMP practices and FDA regulations.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and skills to use them effectively.

Nice-to-haves

• Experience with Solidworks and Minitab preferred.

Benefits

• life insurance
• sick time
• 401(k)