Manufacturing Engineer II - Exempt

Join our dynamic team in Boulder, CO, where you will have the opportunity to work in a vibrant and innovative environment. As a Manufacturing Engineer II, you will play a crucial role in supporting the PMO operations engineering team, driving projects and capital initiatives to run the business and deliver cost savings, while complying with quality and regulatory policies for components used in life saving medical devices.

Top 3 Technical Skills Required

• Project Management
• Manufacturing engineering experience in a regulated environment (Medical Device preferred)
• Financial / Business Acumen

Education and Experience

• Bachelor's degree in Engineering
• 2 years of relevant experience or an advanced degree

Work Schedule and Location

• 40 hours per week
• Onsite, full time at the Boulder Plant

Key Responsibilities

• Manage specific individual MDR project schedules and lead cross-functional teams on engineering and capital projects.
• Manage finances associated with projects, including spend forecast accuracy, drafting POs, capitalization, and tracking capital project budgets.
• Create and own cost savings, capacity expansion, and run-the-business projects from initial proposals through implementation and project completion.
• Execute process and equipment validations through Installation Qualification, Operational Qualification, and Process Qualification (IQ, OQ, PQ) using statistical analysis tools.
• Provide process engineering support for production problems, engineering runs, and equipment or process troubleshooting.
• Author and institute written technical specifications and SOPs through the document control system for new and existing processes and equipment.
• Drive continuous improvement initiatives focused on yield, efficiency, quality, and cost.
• Collaborate with suppliers and contract manufacturers to support equipment implementation, process improvements, and technical alignment.

Specialist Career Stream

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors

• Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.
• Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.
• Innovation and Complexity: Problems and issues faced are general and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve the effectiveness of the job area.
• Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience

Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.