ImpediMed is looking for an experienced Senior Program Manager with medical device experience to join us and work with our marketing, engineering, quality and software teams. This person will manage a portfolio of projects to deliver innovative business models and ensure the commercialization and delivery of our next generation product(s). We are looking for a great Senior Program Manager who will have the appropriate level of business acumen to interact with our internal leaders as well as external business constituents.
ImpediMed is the world leader in the development and distribution of medical devices employing Bioimpedance Spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of fluid status. ImpediMed’s primary product range consists of a number of medical devices that aid surgeons, oncologists, therapists and radiation oncologists in the clinical assessment of patients for the potential onset of secondary lymphedema. ImpediMed has the first medical device with an FDA clearance in the United States to aid health care professionals clinically assess secondary unilateral lymphedema of the arm and leg in women and the leg in men. As we expand we will require new employees to help develop and market our compelling product range.
ImpediMed also markets devices for body composition assessment and fluid status monitoring in a variety of research settings. ImpediMed is developing its BIS technology for use in many other clinical settings.
ImpediMed is an ASX 300 company, and one of the fastest growing small companies on the ASX
Visit our website at: www.Impedimed.com and our stock at ASX:IPD
TO APPLY: Please email: firstname.lastname@example.org, subject line reading: Senior Program Manager 2016
ATTENTION CANDIDATES: Along with your resume, please provide a cover letter explaining your interest in this job opportunity and why you are interested in working at ImpediMed.
The Senior Program Manager, Medical Device will lead multiple cross-functional projects for ImpediMed’s next generation product(s) ensuring completion while adhering to budget, scope and schedule requirements. Projects will be executed within an FDA regulated design & manufacturing environment and be focused on product and process improvements. This role serves as an in-house project consultant, planning and executing project(s) having an internal focus from initiation through delivery.
PRIMARY DUTIES & RESPONSIBILITIES: (Essential Functions of the Position) include, but are not limited to the following. Other duties may be assigned.
• In collaboration with executive management defines project scope and ensures alignment with corporate strategy.
• Obtains buy-in from all appropriate stakeholders.
• Plans and executes all projects while maintaining compliance with ImpediMed’s quality system requirements through training and adherence to policies, procedures and processes within the requirements of the ISO-13485 quality standard and FDA QMS.
• Creates and executes project work plans (Work Breakdown Structure) and revises them as appropriate.
• Identifies required resources and assigns them appropriate tasks.
• Manages day-to-day operational aspects of a project.
• Reviews deliverables prepared by team and leads management project reviews.
• Identifies project risks and defines risk mitigation plans.
• Ensures project documents are complete, current, and stored appropriately.
• Assists in developing an evaluation process to gain feedback from constituents.
• Makes launch date commitments to business and manage stakeholder expectations with regard to program deliverables.
• Influences and communicates effectively with senior leaders inside and outside the company.
QUALIFICATIONS GUIDELINES: (Knowledge, Skills, & Abilities)
• Must understand, follow and comply with regulatory requirements as applicable to various processes. An understanding of FDA Quality System Regulations and ISO Standards (ISO 13485) is required.
• Must possess a thorough understanding of work related standards and regulations, including but not limited to Standard Operating Procedures (SOPs) and Quality System Regulations (QSRs), both US and international.
• Strong program and project management experience
• Practical experience with Lean Six Sigma methodologies and techniques
• Demonstrated attention to detail, thoroughness, and the ability to manage complexity and ambiguity
• Must have good technical writing abilities.
• Experience with cross functional teams is required.
• Excellent verbal communication skills are required.
• Excellent presentation skills are required.
• Excellent time management skills.
• Ability to build positive working relationships, both internally and externally.
MIMIMUM EDUCATION, EXPERIENCE OR CERTIFICATIONS:
• A Bachelor’s degree or Master’s degree in STEM discipline
• A Master’s degree in business a plus
• A minimum of seven (7) years of medical device and project/program management experience.
WORK ENVIRONMENT & PHYSICAL REQUIREMENTS:
• Travel: Position requires business travel (including overnight), estimated at (up to 30%). Must be available for occasional international travel. Valid driver’s licence and valid passport required.
• Physical Demand: Light physical effort.
• Mental Demand: Moderate to high degree of concentration.
• Full healthcare benefits include: Medical PPO/HMO/HSA choices, Dental PPO, Vision PPO; 401(k) with matching program for full-time employees once vested in plan.
• Basic Life, AD&D, STD/LTD, EAP Program
ImpediMed is an Equal Opportunity/Affirmative Action Employer