Intermediate/Senior Development Manufacturing Engineer

Intermediate/Senior Development Manufacturing Engineer Picocyl, LLC - 5.0 Golden, CO Job Details Full-time From $125,000 a year 4 hours ago Benefits Health savings account Health insurance Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Project engineering Requirements specification Mechanical design Bachelor's degree Requirements analysis Manufacturing engineering Mechanical troubleshooting Full Job Description Job Overview We are seeking a dynamic and experienced Intermediate/Senior Development Manufacturing Engineer to join our innovative manufacturing team. In this role, you will drive the development, optimization, and troubleshooting of manufacturing processes for complex products. Your expertise will ensure efficient production workflows, high-quality output, and continuous improvement initiatives. This position offers an exciting opportunity to work at the forefront of manufacturing technology, utilizing your mechanical, industrial, and process engineering skills to make a tangible impact on product development and factory operations.

Responsibilities include:

Manage manufacturing engineering projects: Lead all aspects of projects related to onboarding new product lines, implementing new manufacturing equipment, and optimizing existing production processes. Manage relationships with automation vendors, develop project plans, maintain schedules, and communicate technical and financial progress to leadership.

Develop and implement automation solutions:

Own the technical execution of large-scale automation projects. Analyze customer and product requirements, design components as needed, and generate assembly processes and automation URS documentation. Collaborate with automation vendors on equipment design and integration. Conduct equipment acceptance testing to ensure conformance with specifications. Develop, release, and maintain production work instructions and supporting processes for new equipment implementations.

Validate automation systems and processes:

Apply medical device and automation expertise to develop efficient and robust validation strategies for automated manufacturing processes. Author and execute validation protocols and reports while ensuring timely review and release through the Picocyl quality and document control systems.

Mentor and support engineering teams:

Provide technical guidance and mentorship to fellow engineers by sharing manufacturing engineering knowledge and best practices. Assist team members with problem analysis, troubleshooting, and implementation of effective solutions while supporting execution of project objectives.

Support production operations:

Provide hands-on support to manufacturing operations, particularly for newly transferred product lines and specialized processes. Respond to production issues with urgency, troubleshoot equipment and process concerns, and implement corrective actions as needed. Ensure all activities are properly documented within the Picocyl Quality System through NCRs, Deviations, Engineering Analysis Reports, and Change Orders.

Pay:

From $125,000.00 per year

Benefits:

401(k) matching Employee assistance program Health insurance Health savings account Life insurance Paid time off Vision insurance Application Question(s): How many years xperience in the medical device industry working in an ISO 13485-compliant quality management system?

Education:

Bachelor's (Required)

Experience:

Manufacturing engineering: 7 years (Required) Ability to

Commute:

Golden, CO 80401 (Required)

Work Location:

In person