Project Manager

Job Title : Project Manager

Department: Program Management Office

Reports To : Manager, Program Management Office

FLSA Status : Exempt

Job Summary and Objective:

• Define project scope and schedule for multiple engineering development and/or manufacturing transfer project while focusing on regular and timely delivery of value.
• Define and manage a well thought out project plan, utilizing best project management practices and tools. Engage and lead the project team to successfully execute the tasks necessary and in a timely manner to achieve the anticipated financial outcome.
• Prepare, maintain, and distribute project plans via Microsoft Project or equivalent project software.
• Follow requirements of the Quality Management System (QMS) to execute the project plan and successfully achieve deliverables, through managing the project team along with associated risks and adverse issues.
• Mitigate and/or correct deviations to plans and perform delivery and financial planning for assigned projects.

Essential Duties and Responsibilities:

• Manage technical projects assigned involving, but not limited to, complex disposable medical products.
• Measure project performance using appropriate tools and techniques.
• Balance the project team workload, ensuring the project team meets their committed project deliverables.
• Meet budgetary objectives and adjust project constraints based on financial analysis.
• Maintain accuracy of billable tasks against scope of work to ensure correct and timely customer billings.
• Partner with Production, Supply Chain, Quality and Engineering to ensure project deliverables and manufacturing schedules are realistic, and that commit dates are achievable.
• When required, provide risk assessment and mitigation steps for customer project deliverables and mitigate as needed.
• Must maintain training to all current NextPhase Quality documentation under its Quality Management System, including the Quality Manual and all SOPs as assigned.

Supervisory Responsibilities:

• Provide direction and guidance to members of the established Project Team in support of their active projects.
• Provide guidance to engineering and quality technicians involved with supporting the deliverables of an assigned project.

Required Qualifications and Work Experience:

• Bachelor’s Degree in appropriate field of study or a minimum of 3 years equivalent work experience.
• Strong interpersonal skills including mentoring, coaching, collaborating and team building.
• Strong analytical, planning, and organizational skills with an ability to manage competing demands.
• Proficient computer skills, including ERP systems, SharePoint, word processing, spreadsheet, and presentation applications.
• Balanced business and technical background; Sufficient technical expertise to provide highly credible leadership to development teams. The ability to provide leadership and collaborate with business management and customers in developing strategies and solutions of high business value.
• An ability to collaborate with customers and develop strategies and solutions to engineering development and manufacturing transfer projects.
• Excellent verbal and written communication skills and experience interacting with both business and engineering professionals at all levels.
• Proficient English language reading and writing skills required.
• Possess the ability to establish/maintain a high level of customer trust and confidence, while meeting the company billing and revenue objectives.
• Ability to maintain composure during a stressful and otherwise difficult customer issue, and to remain professional and courteous with customers at all times

Preferred Qualifications and Work Experience:

• Project Management certification - PMP, PMI-ACP, SMC, SAFe, or SA.
• 5+ years’ experience in a medical device (contract) manufacturing or product engineering and development environment.
• Prior experience with processing both plastic and metal materials in the production of medical devices.
• Familiarity and prior experience working under ISO 13485:2016, ISO 14971:2007 and 21CFR Section 820 (FDA QSR).
• Possess a basic business acumen with an understanding of Purchase Order placement, Sales Order processing, Invoicing and Billable Hours tracking, preferably within the framework of ERP software.
• An established track record of completing projects on time and on budget.
• Working knowledge of relational database applications.

Physical Demands:

• Full range of motion for wrist, hand and finger dexterity.
• Sitting/standing, working at a computer for prolonged periods.
• Ability to lift up to 25 lb.

Work Environment:

• Physical Setting : Busy, professional office environment.
• Culture : A diverse and inclusive culture that respects and values individual contributions. Our team engages in regular social events to foster relationships.
• Dress Code: Business casual attire to promote a professional yet comfortable workplace
• Core Business Hours : 8:00am to 5:00pm.

Additional Information:

• This position necessitates full-time on-site presence.
• Occasional travel to customer sites or suppliers may be required.
• Entrance into one of several clean rooms on site will be necessary from time to time, with the requirement of gowning appropriately.