Job Title

Operations Project Manager

Department

Operations

Reports To

VP of Operations & Supply Chain

FLSA

Exempt

Summary

SUMMARY:

The Project Manager is responsible for providing cross-functional project leadership of one or more concurrent development and/or operational projects to achieve desired outcomes. Two main functions are interfacing with external contract manufacturing customers to support their development teams during design and launch of a new product to be manufactured within LifeSync and managing activities and requirements for larger scale operational projects.

Duties And Responsibilities

• Plan and execute assigned projects and maintain accountability to project deliverables; ensure that project objectives and scope are clearly articulated and shared with appropriate parties.
• Maintain clear Gantt charts with specific, measurable, time-bound milestones and critical path and clear project scoping data sheets.
• Manage cross functional project teams that may include local team members, external customers, contractors, and design/manufacturing partners globally (both internal and external to LifeSync).
• Interface with customers to support initial design iterations by giving manufacturing expertise to improve manufacturability.
• Work hand in hand with business development to identify new and enhance customer relationships through clear and concise communication and technical support.
• Understand the capabilities and capacities of LifeSync global manufacturing footprint and be able to translate that into opportunities for new and existing customer expansion.
• Conduct project risk assessments and develop plans to monitor and mitigate project risks.
• Lead project team meetings, update schedules, track action items and maintain project risk register.
• Provide a hands-on approach to creating and/or reviewing documentation including requirements specifications, test protocols and results, validation requirements, and traceability matrices.
• Monitor progress to plan and implement corrective actions or contingencies as needed to maintain commitments.
• Create and conduct project presentations; keep leadership and the project team apprised of progress through routine reports and updates.
• Ensure adherence to LifeSync policies and procedures.
  
  

Requirements

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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

• 5+ years prior technical experience in an engineering design or manufacturing position.
• Skilled in the use of Microsoft Project (or equivalent tool), and other common Microsoft Office tools (e.g., Excel, Word, PowerPoint).
• Well-developed and fluent technical writing skills.
• Strong communication skills including verbal, written and presentation.
• Demonstrated leadership and strong interpersonal skills.
• Ability to identify and resolve conflict and/or communications issues.
• Ability to understand technical standards and disseminate product requirements.
• Ability to work independently and/or lead a team.
• Experience with capital equipment design and manufacturing.
• Ability to persuade, encourage and motivate members of a team.
• Strong sense of accountability, ownership, and commitment to success.
• Ability to interact professionally with high level management and customers.
• Demonstrated root cause analysis and problem-solving skills.
• Demonstrates strong business acumen with a customer centric perspective.
• Experience working in an ISO compliant environment (e.g., ISO13485), and expertise in structured design processes and design controls.
• Mature understanding of design drawings, GD&T, BOM structures and familiarity with ERP systems.
• Knowledge of manufacturing assembly processes, including process qualifications such as IQ, OQ, PQ.
• Familiarity with FDA QSR, and ISO regulations, design controls and regulatory approval methods.
• Familiarity with risk management, dFMEA and pFMEA techniques.
• Experience working with both domestic and international manufacturing partners.
  
  

Supervisory Responsibilities

None. Must be able to manage cross functional teams, both internal and external, to achieve successful completion of the project.

Education And/Or Experience

• Bachelor’s degree in engineering, operations management, life sciences, or related technical field of study.
• Demonstrated experience and results in project management, working in a technical discipline and regulated industry.
• PMP certification preferred.
  
  

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Stand
• Move
• Sit
• Bending
• Stoop, kneel, crouch, or crawl.
• Talk/hear.
• Hand Use
• Repetitive use of hand
• Simple Grasping
• Fine Manipulation
• Use Vision (up close)
• Use Vision (Distance)
• Use Vision (Color)
  
  

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Typical Office Environment
  
  

TRAVEL REQUIREMENT:

Often travel (typically <30%), including cars or domestic and international flights.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

LifeSync provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

The Age Discrimination in Employment Act (ADEA) forbids age discrimination against people who are age 40 or older. It does not protect workers under the age of 40, although some states have laws that protect younger workers from age discrimination. It is not illegal for an employer or other covered entity to favor an older worker over a younger one, even if both workers are age 40 or older.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.