Open Position: Project Manager, Product Development

SUMMARY:

The Project Manager plans, manages, and monitors all phases of the LDT product development program in accordance with the product development process, supporting the full lifecycle of the product development program from initial business case development to product launch and commercialization. The Project Manager position is responsible for delivering new products on spec, on time and on budget while meeting regulatory and company design control requirements. The individual may also support platform product lines of Epic Sciences.

ESSENTIAL FUNCTIONS:

  • Supports the strategic direction and intent of the product development program
  • Applies project management oversight of complex product development programs, to achieve strategic business goals through new product delivery and commercialization
  • Maintains continuous alignment of Design & Development Plan with strategic business goals
  • Works cross-functionally and consults frequently with Research and Development, Quality, Regulatory, Marketing, Operations and other functional groups
  • Communicates plan goals, status, requirements and deliverables to all team members, stakeholders, and sponsors
  • Documents and tracks milestones and monitors adherence to Design & Development plan and schedule
  • Establishes and maintains Design History File and Project Business File documentation
  • Ensures development of the project budget, schedule, resource management, and performance of assigned projects
  • Manages the program critical path including risk management and contingency planning.
  • Measures and reports cost and schedule performance against objectives
  • Applies project management processes to achieve the highest team performance and value added effort
  • Works effectively with team members at all levels
  • Coaches and develops core team members as necessary to assure common understanding of the product development process
  • Effectively communicates and maintains visual tools for program or project tracking and management
  • Effectively learns and employs Epic processes, tools and concepts to maximize efficiency and quality

ADDITIONAL DUTIES:

  • May perform additional duties as assigned or directed by management from time to time.

EDUCATION/EXPERIENCE REQUIRED:

  • Bachelor’s degree or higher in Life Science, Engineering, Medical device business management or related field or equivalent work experience is required.
  • Minimum of 5-7 years of relevant work experience in scientific or engineering product development and/or project management
  • Experience in a CLIA based LDT or regulated LDT environment

Preferred:

  • Project management Professional (PMP) certification or similar certification or formal training
  • Experience in a CLIA and CAP accredited laboratory setting
  • Understanding of ISO and FDA regulations with regards to design, process, and document control, process validation, and GLP

REQUIRED SKILLS:

  • Demonstrated experience in project management of product development projects
  • Expert user of Microsoft Project
  • Strong motivational leadership skills and the ability to influence others without direct authority is required
  • Strong written and oral communication skills
  • Highly self-motivated
  • Strong time management and planning skills
  • Exceptional interpersonal and communication skills, works well with others
  • Close attention to details, ability to troubleshoot and maintain accurate records

REQUIRED COMPETENCIES:

  • Performance Orientation – Is driven by personal performance; achieves all objectives detailed in scorecards and comfortable with quantifiable assessments.
  • Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
  • Competitive – Dedicated to a competitive spirit that supports the Epic Sciences’ goal to be the premier CTC technology in the industry.
  • Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
  • Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
  • Confidence - Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms.
  • The employee must occasionally lift and/or move up to 10 pounds.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • Standing for long periods of time.
  • Transition from standing and sitting often.

WORK ENVIRONMENT

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • General office environment. Daily exposure to PCs and networks.
  • May move heavy equipment and boxes.
  • While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles; toxic or caustic chemicals and risk of electrical shock. The employee is frequently exposed to risk of radiation and vibration. The employee is occasionally working near moving mechanical parts; extreme cold (non-weather) and extreme heat (non-weather).
  • The noise level in the work environment is usually moderate.

Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

Epic Sciences is an Equal Opportunity Employer and committed to the principle of diversity.

To apply, email your resume and cover letter to [email protected] and reference the job in which you are interested.