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
Qualifications
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.
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.
