Position
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Position Summary |
We are seeking a skilled Project Manager with a proven track record in project management, capable of leading multiple concurrent projects seamlessly. The ideal candidate possesses a relentless commitment to project execution, coupled with strong financial acumen and a solid technical foundation with experience launching medical products in Chemical and Life Science products. If you thrive in a fast-paced environment, excel at cross-functional collaboration, and want to work for a company that is passionate about protecting patients and raising the standard of care in healthcare, we encourage you to apply. |
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Duties and Responsibilities |
Position Summary |
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We are seeking a skilled Project Manager with a proven track record in project management, capable of leading multiple concurrent projects seamlessly. The ideal candidate possesses a relentless commitment to project execution, coupled with strong financial acumen and a solid technical foundation with experience launching medical products in Chemical and Life Science products. If you thrive in a fast-paced environment, excel at cross-functional collaboration, and want to work for a company that is passionate about protecting patients and raising the standard of care in healthcare, we encourage you to apply. |
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Performs other duties assigned as needed |
| Qualifications |
Education: High School or Equivalent Associate’s Degree Bachelor’s Degree Master’s Degree PhD Degree Bachelor’s Degree in technical or technology related field required. Preferred Advanced degree (Master’s Degree or Ph.D.) |
Years of Related Experience:
- 5 years of related PM experience, at least 3 years’ experience in the Medical Device industry field required;
- Experience launching new Chemical and Life Sciences products to market from concept to launch
- Minimum of 3 years of related professional experience with process improvement, metrics and project management leveraging continuous improvement tools and processes
- Preferred prior experience in Lean Business Systems tools and processes, such as Visual Project Management, Risk Management, Daily Management, Problem Solving and Kaizen
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Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations: (Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)
- Knowledge and application of design controls within the framework of Medical Device Regulations (21CFR820, ISO 13485), ensuring that every design step meets the rigorous standards required in the medical device industry.Strong business acumen with experience in understanding ROI evaluation.
- Proven track record of successfully leading Engineering/Technical projects to deliver on objectives.
- Demonstrated success in the management of complex projects in Engineering/Technical field.
- Excellent problem-solving skills with the ability to analyze complex data, identify root causes, and develop practical solutions.
- Track record of leading others to pursue challenging goals and to challenging the status quo to develop breakthrough solutions.
- Strong interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams and influence key stakeholders.
- The ability to set high standards for results (refuse to fail mentality), and once achieved, raises the standards even higher. Holds people accountable for meeting commitments and getting results.
- Creates an environment that encourages risk-taking and ensures inclusion of varied perspectives.
- Metric driven attitude with high level of accountability for performance
- Proficiency in project management tools and software.
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| Responsibility for Others and Internal Interactions |
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- This role will report to the Sr. Director of PMO
- Potential internal interface activities that the position may encounter include:
- R&D Directors, Quality, Operations, Marketing, Regulatory Affairs, Service and Support on project planning/execution
- R&D managers and individual contributors
- Managers and individual contributors from cross-functional groups planning and executing projects
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| External Interactions |
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• Visit external partners, customer sites or market research facilities, occasionally •Regular communication with development partners (e.g., product design companies) |
| Environmental, Health and Safety |
All managers and employees shall proactively support ASP’s Environmental, Health and Safety (EHS) Policy by providing the necessary resources and giving equal emphasis with other functions such as production and quality. It is the duty of every manager and employee to: Ensure implementation of safety and environmental procedures, guidelines and standards. Evaluate employee compliance and enforce established safety and environmental procedures and rules. Create a safe work area environment, recognize safe activities, and reward good safety performance. Provide training to employees when:
- Hired
- Transferred
- New substances, processes, procedures or equipment are introduced to the workplace and represent a new hazard
Measure safety performance and hold persons accountable for activities and results. Ensure that incidents are investigated to determine root cause, and that corrective actions are taken. Ensure employees wear required protective equipment. Ensure EHS inspections are conducted monthly, and corrective actions are implemented. |
| Occupational Hazards |
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Ergonomic Risk: LowReproductive Health Risk: No Concern ☐ Machine Operation ☐ Electrical Hazards ☐ Laser Hazards ☐ Excessive Noise (>85 dB) |
☐ Heights (> 6ft) ☐ Hazardous Chemicals/Fumes ☐ Excessive Dust ☐ Bloodborne Pathogen ☐ Biohazards (BBP and parts of LAH) ☐ Extreme Heat/Cold |
| ☐ Other Hazards:Click or tap here to enter text. |
| Powered Industrial Vehicles (PIV) Operation |
☒N/A |
☐Forklift ☐Motorized Pallet Jack |
☐Company Vehicle |
Lifting Requirement |
☒N/A |
Choose an item. |
☐ Ground to knees ☐ Ground to Waist ☐ Ground to Shoulders |
☐ Ground to Overhead ☐ Waist to Shoulders ☐ Waist to Overhead |
| Repetitive Hand Motions |
☐N/A |
☐ Twisting Motion ☒ Computer Entry |
☐ Simple Grasp ☐ Fine Manipulation |
| Additional Environmental, Health and Safety |
☒N/A |
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| Compliance |
All employees have a duty to comply with applicable laws, regulations, standards, ASP policies and procedures. This job description is intended to convey information essential to understanding the scope of this position and it is not intended to be an exhaustive list of skills, efforts, duties, responsibilities or working conditions associated with the position. Employees are required to follow any other job-related instructions and perform job-related duties as may be reasonably assigned by his/her supervisor. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties of the job. |
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In accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position will:
- Lead New Product Development and Life Cycle Management projects collaborating closely with cross-functional teams (including R&D, Ops, Prod. Mgmt., RA/QA) to navigate through all activities required to design, develop and commercially release products
- Utilize project management best practices to develop comprehensive project plans, establish timelines, allocate resources, and track progress towards cost-saving targets.
- Establishes strong operating mechanisms to track progress, identify issues, overcome obstacles, and define recovery plans.
- Drive continuous improvement efforts by implementing lean methodologies, process optimizations to achieve cost reduction targets.
- Works with QA/RA to ensure full compliance with the QMS, FDA design controls, and global regulatory agency requirements.
- Participate in the planning, implementation, operation and maintenance of the Project Priority List (PPL), as part of Lean Portfolio Management
- As a member of the PMO team, own and/or support continuous improvement (e.g. efficiency, effectiveness, employee engagement)
- Develop and maintain strong relationships with internal stakeholders, suppliers, and external partners to support the successful execution of projects.
- Communicate project status, risks, and opportunities to senior management, providing regular updates and recommendations for course corrections as needed.
- Effectively use Fortive Business Systems (FBS) tools and processes, such as Agile Project Management, Visual Project Management, Risk Register, Daily Management, Problem Solving and Kaizen, to accelerate product delivery to the marketplace
- Exhibit and lead on the “Fortive 9” set of core behaviors: Customer-obsessed, Adaptable, Delivers Results, Strategic, Leads with FBS, Innovates for Impact, Inspires, Exhibits Courage, and Builds Extraordinary Teams
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