Engineering Project Manager - Critical Engineering Systems
ob Title: CES Project Manager
Department: Facilities
Effective Date: 4/1/2022
Location: Alachua, FL
While this is intended to be an accurate reflection of the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
SUMMARY:
RTI Surgical is global, industry-leading private label OEM with expertise in allograft, xenograft and synthetic-based implants. RTI began operations in 1998 when it spun off from the University of Florida Tissue Bank in 1998 with the goal of expanding the gift of tissue donation by pioneering tissue-based innovations that promote natural healing. Today, through integrated partnerships with customers, RTI develops and delivers restorative solutions to physicians and their patients.
As a Private Label Original Equipment Manufacturer (PLOEM) partner, RTI provides comprehensive turn-key services for development and product life cycle management in support of patients and leading medical technology companies. RTI’s implants are used in multiple surgical applications including dental, spine, sports medicine, plastic and reconstructive surgery, urology/urogynecology and trauma.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on four key values:
- We are accountable to each other by trusting each other’s judgement and hold each other responsible for results.
- We find joy by striving to create a working environment that people enjoy.
- We fully engage by focusing our hearts and minds on our customers, patients, and each other.
- We adapt to change by working collaboratively to be flexible to the changing needs of our business.
RTI’s headquarters is located near Gainesville, Fla. in North Central Florida’s growing life sciences region, and has additional state-of-the-art facilities in the Greenville, N.C. and Germany.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and have supported the transformation of the company to its next level of potential.
RESPONSIBILITIES:
- Provides engineering for maintenance of physical plant with a focus on critical engineering systems (CES), in a biomedical manufacturing facility.
- Applies engineering principles to research, design, budget, specify, purchase, install, document, maintain, and make improvements to equipment and systems.
- Provides technical support, troubleshooting, problem solving, and resolution of equipment and system related problems.
- Prepares or directs preparation of design drawings, plans and specifications for engineering projects.
- May manage technical staff and contractors and inspects their performance during project construction, for successful compliance with project requirements.
- Leads the engineering design process for assigned projects, with responsibility for successful adherence to company standards, specifications, budgets, schedules, and regulatory requirements (such as FDA, AATB, and local, State, and Federal agencies).
- Collaborates with other engineers, technical staff, managers, processors, contractors, regulatory agency representatives, and local government officials.
- Evaluates the feasibility and cost of implementing proposed engineering projects; performs economic analyses (i.e., life-cycle-cost, return on investment) on major equipment items.
- Prepares budgets and justification for engineering projects and purchases and presents recommendations to senior management.
- Required to work a significant number of evening, weekend, and holiday hours as dictated by project needs during Operational downtime.
- Analyze workflow, space requirements, and equipment layout in order to maximize efficiency.
- Proactively collaborates with other functions to identify possible solutions to improving productivity, efficiency, simplification, or support innovation.
- Works closely with business stakeholders, subject matter experts, project managers, and others to track projects to successful completion.
- Critically evaluates information gathered from multiple sources, reconciles conflicts, decomposes high-level information into details, abstracts low-level information to a general understanding, and distinguishes user requests from the underlying business needs.
- Identifies risks in processes or assets, using FMEA or similar tools, and works with stakeholders in mitigating risks.
- Prepares project plans (on Smartsheet, MS Project, or similar tools), project status reports and shares with stakeholders.
- Develops multi-phase strategy for larger projects to deliver value in each phase.
- Other duties as assigned.
EDUCATION/EXPERIENCE REQUIRED:
- Associates Degree, (Bachelors preferred) with discipline in Engineering
- 2+ years in project management
- Experience using Microsoft Office, Solid Works and CAD Systems. Prefer intermediate/advanced experience in Microsoft Excel.
- Experience following detailed and accurate project task and schedules, and solving equipment related conflicts and issues.
- Great attitude in high pressure situations with ability to negotiate and influence effective outcomes and drive results.
- Strong work ethic and track record of taking on additional responsibility.
Physical Requirements:
Light work: Physically handle objects up to 20 lbs. occasionally.
Work Environment:
Office Setting - Open layout with assigned work station or office