PURPOSE/SUMMARY (Brief overview of why job exists, general purpose for position)

The OEM Project Manager will lead and manage cross-functional teams as well as an individual contributor to ensure accountability and timely deliverables resulting in on time program completion. The Project manager will be responsible for both new product introductions (NPI) as well as sustaining management for active OEM products and activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES (List of 8 – 10 key tasks required of the job which occupy greater than 5% of the incumbents time)

Project Development and Tracking

·         Work with project stakeholders to define project milestones and resource requirements

·         Proactively identify and assess areas of risk and propose solutions

·         Consistently monitor and report on progress of the projects to all team members and prepare an executive overview as needed

·         Conduct routine meetings to ensure accountability and milestone achievements

·         Implement and manage project changes and interventions to achieve timely project outputs

Manage Design History File (DHF) for OEM Product Launches

·         Ensure compliance to FDA regulations for proper DHF file creation and maintenance

·         Coordinate cross functional teams (Marketing, R & D, Regulatory, Quality, Supply Chain) to ensure closure of New Product Development (NPD) checklist deliverables

·         Responsible for confirming the OEM supplier has performed all required tests and related documentation completion

       OEM Product Maintenance

·         Create medical device purchasing specification

·         Work with OEM suppliers to implement product and process change

·         Ensure OEM product documentation (i.e.; IFU, labelling, packaging, etc.) accuracy and manage updates as needed

·         All other essential related duties as required

SUPERVISOR RESPONSIBILITIES (IF ANY) – Optional section (List of subordinate jobs for which this job has direct hire/discipline/budget responsibility)

No direct reports

MINIMUM QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE

• 4 year Engineering or Business degree in required
• 5+ years of experience in the medical device field
• 2+ years of program management experience

ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES

• Must have hands on Oracle knowledge 
• Fluency with Microsoft Office, including Microsoft Project
• Knowledge of FDA and ISO 13485 regulations
• Ability to work independently and as a team

• Position requires some travel throughout the United State
• Excellent verbal and written skills.
• Organizational, analytical and problem solving skills

 Gyrus ACMI is an Equal Opportunity/Affirmative Action Employer