Pleasanton, California Pleasanton, CA 94566
Job Title: Manufacturing PM
Location: Pleasanton, California - 94566
Job Type: Contract
Duration: 6 months
Essential Job Responsibilities:
- Manages complex manufacturing implementation of medical device projects within the Business Unit
- Guides development and documentation of packaging, labeling, product manuals, and manufacturing procedures and resolves team obstacles.
- Assures the development of multi-level project planning to achieve short and long-term business objectives
- Keeps the senior management team informed of development/implementation progress and issues.
- Develops functional departmental budgets and coordinates cross-functional project budgets
- Develops and communicates key performance indicators (cost/schedule/technical/
quality) for projects.
- Provides design/development teams with appropriate resources to perform assigned tasks.
- Interfaces with appropriate internal resources (regulatory, quality, manufacturing engineering, etc.) and external suppliers to ensure development programs meet quality and customer requirements.
- Reviews and provides functional approval for project and quality system documentation.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Education & Experience You’ll Bring:
- Bachelor’s Degree in a technical field (i.e. Sciences, Engineering) or related discipline
- 5+ years of medical device development experience and managing complex, multi discipline (manufacturing, labeling, mechanical) devices
- Managed cross discipline (Quality, Regulatory, Operations, Marketing, etc) development teams and/or programs
- Working knowledge and experience with 21 CFR 820.30 and European Medical Device Directive
- (application to medical devices); European MDR experience also helpful.
- Proficient with MS Project, Excel, and PowerPoint as well as electronic document control systems
- Budget planning and management experience
- Excellent verbal and written communication skills, with ability to communicate to all levels of the
- Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization
- Ability to travel 10% of the time
- Preferred Qualifications:
- Advanced level degree in technical and/or science field or related discipline
- PMP certification
- Medical Device Labeling experience
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities
Reach Out To A Recruiter
Recruiter: Jeff Kasula
Phone: (678) 890-5105