Manufacturing Program Manager

Benefits :

401(k)

401(k) matching

Bonus based on performance

Dental insurance

Health insurance

Description :

The Engineering Program Manager is accountable for the overall program success through the full customer engagement life-cycle, from requirements definition, proposal offering, contract negotiations, executable plan for product development, validation / qualification test, final acceptance, all in support of the design control process, while maintaining strict compliance with the Cogmedix Quality System, 21 CFR 820 and ISO 13485.  Success is measured by business metrics, audit results and customer satisfaction.  The Engineering Program Manager will be responsible for multiple Programs, and Programs may consist of single or multiple Projects within the Program, largely dependent upon size and complexity.  This role is responsible for maintaining customer and internal dashboards and time management / audit of the engineering staff.

Responsibilities

• Lead and manage engineering projects, ensuring alignment with company goals and regulatory requirements.
• Collaborate with cross-functional teams to define project scope, objectives, and deliverables.
• Monitor project progress and performance, providing regular updates to stakeholders.
• Ensure compliance with FDA regulations throughout the project lifecycle.
• Utilize Microsoft Excel for data analysis, project tracking, and reporting.
• Facilitate effective communication among team members and external partners.
• Identify risks and develop mitigation strategies to ensure project success.

Qualifications

• Bachelor's Degree in Engineering, Project Management, or a related field.
• Proven experience in project management, preferably in a regulated environment.
• Strong understanding of FDA regulations and compliance standards.
• Excellent communication skills, both verbal and written.
• Proficient in Microsoft Excel for data management and analysis.
• Ability to work collaboratively in a fast-paced environment.
• Strong problem-solving skills and attention to detail.

Cogmedix is an Equal Opportunity Employer. Cogmedix does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.