R&D Project Manager (34657)

Kls Martin Lp; Jacksonville (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

KLS Martins is seeking a Project Manager to drive intensive, mission-critical R&D projects for medical devices. You will lead a cross-functional team from concept through sales release, guiding design controls and ensuring on-time delivery of innovative products.

The role requires strong leadership, excellent communication, and ability to coordinate with marketing, engineering, and operations to overcome roadblocks and ensure successful product launches.

Qualifications

• BS in Engineering Mechanical or related field required.
• Strong communication and organizational skills required.
• Experience in estimating engineering personnel needs and scheduling work.

Responsibilities

• Lead cross-functional resources assigned to new R&D product development projects.
• Communicate project status and coordinate all project activities.
• Create and maintain Design History Files (DHF) for project assignments.
• Maintain timelines and documentation for design control per FDA GMP 820.
• Collaborate with marketing, engineering, and operations to keep projects on schedule.
• Identify critical path activities and mitigate schedule risks.

Skills

Project management

Cross-functional leadership

Communication

Scheduling

Design history file awareness

Education

BS in Mechanical Engineering

Tools

MS Project

Wrike

Windchill

Job description

Job Details

Job Location: Jacksonville, FL 32246

Position Type: Full Time

Education Level: 4 Year Degree

Travel Percentage: Negligible

Job Shift: Day

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

Qualifications

• 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
• Adheres and supports 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