Job Summary
The Project Manager will take-on intensive, mission critical project management for the R&D Department team. These efforts will directly contribute to delivering innovative medical devices to surgeons, hospitals, and their patients. This includes leading and directing a cross-functional new product development team, coordination of all project related activities from concept to sales-release and resolving any project road blocks or obstacles to the successful release of the new product. Strong leadership skills are essential to be successful in this position.
Essential Functions, Duties, and Responsibilities
- Lead cross-functional resources assigned to new R&D product development projects
- Communicate project status and coordinate all project activities
- Strong organization skills to create Design History Files (DHF) for project assignments
- Maintain timelines, action item lists, and all necessary documentation for design control per FDA GMP's section 820 for medical devices and internal procedures
- Work closely with marketing, engineering, and operational departments to keep critical projects on schedule
- Plan and facilitate product development projects, normally consisting of multiple low-complexity projects and one major project
- Schedule teams work to meet completion dates and technical specifications
- Review and evaluate results of project activities
- Recommend changes in methods, design, or equipment where necessary
- Maintain project design history files in accordance with regulatory requirement
- Performs other related duties as assigned or requested
- Identify critical path project activities and mitigate project schedule risks
Educational and Experience Requirements
- BS in Engineering Mechanical or highly related engineering field
- Minimum 4 years professional work experience, preferably in a project management role.
- Excellent communication skills are essential to facilitate meetings, status updates, presentations, and documentation
- Experience in estimating engineering personnel needs and scheduling work to meet completion dates and technical specifications
- Ability to maintain project schedules and proficiency in Microsoft MS Project or Wrike
- Displays personal accountability and credibility
- Proficient user of other Microsoft Office applications
- Prior Windchill experience would be a plus
Knowledge, Skills, and Abilities
- Maintains high integrity and confidentiality of company and department information.
- Adhere and support KLS Martins quality and safety policies and procedures.
- Ability to retrieve and interpret documentation.
- Able to work independently under minimal supervision.
- Ability to plan, conduct and supervise engineering assignments
- Able to efficiently communicate and collaborate amongst a team.
- Strong interpersonal skills with the ability to effectively communicate at all levels internally, as well as externally.
- Problem solving and decision making
- Understand design specification development and apply to project assignments.
- Adaptability & flexibility
- Ability to work with international Engineering and Regulatory teams.
- High level of customer service displaying positive attitude.
Skill Requirements
- Typing/computer keyboard
- Utilize computer software (specified above)
- Retrieve and compile information
- Maintain records/logs
- Verify data and information
- Organize and prioritize information/tasks
- Operate office equipment
- Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
- Verbal communication
- Written communication
- Public speaking/group presentations
- Research, analyze and interpret information
- Investigate, evaluate, recommend action
- Leadership and supervisory, managing people
- Basic mathematical concepts (e.g. add, subtract)
- Abstract mathematical concepts (interpolation, inference, frequency, reliability, formulas, equations, statistics)
Physical Requirements
- Sitting for extended periods
- Extended periods viewing computer screen
- Walking
- Reading
- Speaking
- Hear/Listen
- Maintain regular, punctual attendance
- Lifting/carrying up to 20 pounds various items
- Pushing/Pulling
- Bending/Stooping
- Reaching/Grasping
- Writing
Hazards
- Normal office environment
Skills Required
- BS in Mechanical Engineering or closely related engineering field
- Minimum 4 years professional work experience (preferably project management)
- Experience creating and maintaining Design History Files (DHF) and design control documentation per FDA GMP 820
- Proficiency with Microsoft Project or Wrike
- Proficient user of Microsoft Office applications
- Experience estimating engineering personnel needs and scheduling work to meet completion dates and specifications
- Strong leadership, communication, interpersonal, problem solving and decision-making skills
- Ability to work with international engineering and regulatory teams
- Ability to work independently under minimal supervision and maintain accountability
- Prior Windchill experience
What We Do
KLS Martin LP is a pioneer in craniomaxillofacial (CMF), thoracic, and patient-specific implant solutions. As part of the KLS Martin Group, it develops and markets innovative medical technology solutions, including implant systems, sterilization containers, and surgical instruments for various surgical fields such as plastic surgery and neurosurgery, dedicated to the passion for surgical innovation to improve medical outcomes worldwide.
