SUMMARY (PRIMARY FUNCTIONS)
The primary objective of the Program Manager is ensuring that project deliverables map to business objectives, with responsibility for the creation, organization, execution and completion of specific projects. This involves collaborating with and managing Key Contractors in various and remote locations involved in design, manufacture, test, and product fulfillment activities required for the development, transfer to manufacturing, and commercialization of Sterifre Medical Inc. products. The Program Manager is responsible for establishing milestones and deadlines, communicating with Company executives timely and consistently about the state of the project, ensuring projects stay on track and on budget, and adjusting if necessary, to meet new requirements. The Program Manager will also serve as the technical lead for Sterifre Medical, Inc., providing input for design, test, manufacturing, and risk analysis while adhering to quality management system processes established by Sterifre Medical and design and manufacturing partners.
This position does not require lifting more than 40 lbs.
INTERNAL AND EXTERNAL CUSTOMER CONTACT
This position requires excellent rapport with internal and external associates and partners of the Company. Direct interface and continuous, timely, documented communication with all individuals responsible for assigned deliverables. Continuous and judicious communication with executive management of the Company.
DUTIES AND RESPONSIBILITIES
- Manage scope, schedule, quality, resources, finance and risk of project, with direction and involvement of executive management as essential.
- Partner with other external Program Managers and project leads to ensure project is successfully within budget, timeline, and scope.
- Provide technical direction to design partners and contract manufacturers.
- Manage project profitability; plan, track and approve project expenses, billing and invoices. Oversee the creation of goals and strategy throughout project.
- Manage expectations of management and team members, and manage the process from assessment and definition, creative and technical design, production and development, testing and launch.
- Create and oversee project schedules; ensure timely completion through all phases; write and present project plans/risks in collaboration with other team members and develop required documentation for all projects.
- Provide reports and analyses to executive management on regularly scheduled basis, upon request, and as determined by events.
- Other duties and responsibilities as assigned.
OFFICE TECHNOLOGY RESPONSIBILITIES
- Experience with the operation of basic computer programs and associated systems is essential. Must be proficient in Microsoft Word, Excel, PowerPoint, and Project, or other equivalent project management software programs. Must attain high level of expertise with Sterifre programs and processes.
- Proficiency with CAD software and ability to analyze CAD files and 2D drawings
- Familiarity with engineering analysis tools (i.e., CFD, FEA, etc.)
- Wide range of types of manufacturing processes (i.e., machining, injection molding, blow molding, coating methods, mechanical and electrical assembly, etc.)
- Software-controlled systems
- Design and development controls (ISO 13485 and FDA Quality System Regulations)
- Production and process controls (ISO 13485 and FDA Quality System Regulations)
- Quality management systems (ISO 13485 and FDA Quality System Regulations) and relevant standards and regulations
- Design of experiments
- Verification and Validation testing
- Dual ability to maintain the broad vision required for executing a project, including strategic thinking and leadership from beginning to end, as well as the talent for overseeing all the small details that add up to successful product completion.
- Entrepreneurial attitude coupled with strong business acumen.
- Self-driven with proven experience working with multi-disciplinary teams.
- Effective negotiator, problem solver, comfortable navigating ambiguity and defining next steps for team members.
- Proven track record in presenting work and the ability to link people, (including team members and stakeholders), ideas, and information throughout a project life.
- Highly developed written and verbal communication, interpersonal skills, strong organizational skills.
- Exceptional ability to communicate between technical and non-technical contributors in a contextually intelligent manner.
- Conscientiously manage and follow up on multiple concurrent tasks and requests on tight deadlines.
- Read what a team needs to help motivate them. Dig in and figure out how to work around problems. Exemplify a “yes and Why Not?” posture.
- Proactive in identifying and resolving problems before they occur.
- Effective critical thinking skills to tease out the risks in plans, eliminate blockers, and ensure on-time project delivery.
- Take ownership of complex efforts and mediate between competing interests and personalities to get alignment and motivate change.
- Create comfortable and encouraging team environment among various and remote partners.
- Innate ability to bring people together and create examination around ideas.
- Communicate accurate, timely information between the Company and all project team partners.
- Travel up to 30% as required.
- Bachelor’s degree in Mechanical or Electrical Engineering
- Master’s degree preferred
- Project Management Professional (PMP) from the Project Management Institute, or
- International Project Management Association (IPMA)
- Minimum of 10 years in an FDA/EPA regulated environment, with 5 or more years of project management experience.
- Alternative to minimum experience/education preferred: Appropriate, relevant on-the-job experience may be considered for minimum requirements.