Mechanical Manufacturing Engineer

How You Contribute to Pinnacle Transplants Success

People who thrive on working for a growing company and want to make their mark on an organization will want to read about this opportunity. Established in 2010, Pinnacle Transplant Technologies is a multi-service tissue bank committed to honoring the gift of donation and improving patients quality of life through the processing and distribution of high-quality allograft implants. We offer a comprehensive portfolio of products and solutions across multiple market segments, including Spine, Sports Medicine, General Orthopedics, Trauma, Dental, and Regenerative Medicine. For over a decade, Pinnacle has helped surgeons improve the lives of thousands of patients. Pinnacle is registered with the Food and Drug Administration (FDA) and accredited by the American Association of Tissue Banks (AATB).

The Manufacturing Mechanical Engineer may be responsible for all or multiple stages of a project relating to creating, maintaining, and improving production equipment and/or infrastructure in the manufacturing cleanroom environment. He/she is expected to contribute individually or on a team to the success of projects by brainstorming solutions, refining ideas, and using existing or devising new processes to evaluate or improve equipment, tooling, job aides, product or process performance. The Manufacturing Mechanical Engineer will possess technical expertise and experience with mechanical design, manufacturing, and process control with proficiency in project management.

Who You Partner With

Daily written and verbal communication with R&D, Quality, Regulatory, and Operations to ensure all duties are understood and executed in a timely manner while in compliance with applicable regulations.

Regular communication with R&D, Quality, Regulatory, and Operations to ensure all processes and products are in compliance with PTT policies and applicable regulations.

Bachelors Degree in Engineering/Science (Biomedical, Chemical, or Mechanical Engineering preferred)

• Minimum of 5 years of process or manufacturing engineering experience within a pharmaceutical, medical device, biologic, tissue bank, diagnostic, hospital, or similar organization
• Minimum of 3 5 years of experience participating in process development, equipment qualifications, process validation protocols and reports, and executing validation protocols
• Experience in applying statistical methods and lean manufacturing principles for product, process, and quality improvements.

Project Management experience is preferred.

Knowledge and experience with CNC and CAD programming, 3D printing, and rapid prototyping is required.

Experience in design control and process validation, process capability, control, and monitoring analysis, root cause analysis, corrective and preventive action (CAPA), sterilization validation, and packaging validation is preferred.

What You Will Do

• Develop, evaluate, improve, and document manufacturing processes
• Analyze and optimize manufacturing process flows continually for the enhancements of quality, cost reduction, and throughput
• Design, author, and lead installation, operational, and performance qualifications (IQ, OQ, PQ)
• Develop and implement process control and monitoring techniques within manufacturing environments
• Partner with vendors in determining product and/or process specifications and arranging equipment, parts, or material purchase, and evaluating according to quality standards and specifications.
• Develop process parameters, inputs, and testing required to validate a new or improved manufacturing process & equipment
• Complete projects within allotted timelines and budget
• Interface with suppliers for new processes, quality issues and process improvements for assigned projects
• Improve manufacturing efficiency by analyzing and planning workflow, space requirements, equipment requirements &layout and making recommendations to Engineering Management
• Create and drive the development and implementation for process and equipment validation strategies
• Lead process design, development, and implementation of new products and capital projects
• Conduct process FMEAs, Design of Experiments, and risk analyses
• Lead engineering reviews as appropriate
• Lead project teams with internal departments to support product and/or process design and development activities
• Participate as a Subject Matter Expert (SME) in relevant internal and external audits
• Work closely with Operations leadership to develop, coordinate, and implement technical training for associates.
• Work with the production planning team in estimating staffing requirements, production times, and relative costs to provide data for operational decisions
• Work to create and/or refine appropriate preventative maintenance procedures and schedules
• Work to create and/or refine appropriate calibration procedures and schedules
• Collaborate with New Product Development, Operations, and outside vendors regarding product tooling, equipment, and gauge design as well as product design to ensure effective production methods
• Provide support to Operations department to troubleshoot and resolve technical problems
• Support company policies and procedures, goals and objectives, FDA and AATB regulations, local, state, and federal laws, and good manufacturing practices

Additional Desired Qualifications

Ability to complete assigned tasks with minimal supervision. This could include creating detailed and accurate project task and schedules, interfacing with project team members and other support personnel and solving simple project-related conflicts and issues

Ability to create and maintain internal data and documentation according to company policies for assigned projects. Ability to organize and prepare presentation of materials for internal or external technical reviews

Provides input to more senior engineers and team members on materials for internal technical reviews

Ability to solve simple problems and design simple experiments

Ability to resolve technical issues within the scope of one's core educational expertise with assistance and monitoring from more experienced staff

Ability to provide internal communication on technical results and issues, both verbally and in written form

Ability to design and program using CNC and CAD (Solidworks)

Ability to work collaboratively with others

Ability to communicate openly and honestly

Ability to complete standard design and engineering tasks without assistance in the scope of core educational expertise

Knowledge of six sigma, kaizen, or similar mechanism for process improvements

Knowledge of process control techniques and methods

Benefits/Total Rewards

Comprehensive medical, dental, and vision insurance, eligible first day of the month following your start date

Company-Paid Short and Long-term Disability Insurance

Company-Paid Identity Theft Protection

Company-Paid Life Insurance Policy of $50,000

401(k) Profit Sharing Plan with a 4% company match, eligible first day of the month following 90 days of

employment

Additional benefits such as: Additional Life/AD&D, Accident, Critical Illness, and Pet Insurance

Paid Time Off:

(4) weeks paid vacation, given at time of hire

(1) week paid sick time, accrued per pay period beginning after 90-days of employment

(10) annual paid holidays