RTI Surgical Inc

Sr. Design Transfer Engineer

RTI Surgical Inc • $90K — $120K *
Eden Prairie, MN 55347In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a relevant area
  • 6+ years in medical device, pharmaceutical, or regulated industry
  • Strong attention to detail and documentation practices
  • Ability to work independently in a small-company environment
  • Effective communication and cross-functional collaboration
  • Problem-solving and investigative mindset
  • Strong knowledge of microbiological techniques and aseptic processing

Responsibilities

  • Serve as a lead core team member on cross-functional projects focusing on process development
  • Perform scientific evaluations to ensure methods meet industry standards
  • Apply six sigma methodologies to translate product design into process specifications
  • Engage with the scientific community to enhance experimental outcomes
  • Suggest and implement creative solutions for process development and testing
  • Coordinate validations and manage documentation for regulatory compliance
  • Leverage clinical and technical expertise to identify and mitigate project risks
  • Exhibit autonomy by directing projects and supporting product development

Benefits

  • Annual CIP bonus opportunity of up to $10,000.00
Full Job Description
Location: Eden Prairie, MN

Annual CIP bonus opportunity of up to $10,000.00

RESPONSIBILITIES

  • Serves as a lead core team member of a cross functional project team whose responsibilities include conducting studies directed toward the development of processes
  • Performs standard scientific assignments to evaluate results for validity and conformance to acceptable scientific methods. Independently determines requirements and acceptance criterion associated with testing performed.
  • Applies deep knowledge of six sigma methodologies (process capability, SPC, etc.) to assess product design and translate them into process specifications
  • Participates and consults with the internal and external scientific community to maintain a state-of-the-art knowledge for application to achieving successful experimental outcomes
  • Deploys deep knowledge of manufacturing to suggest and implement creative solutions in process development and test method creation innovating manual hand driven processes to semi-automated equipment driven processes.
  • Coordinates or performs validations and documents risk management activities to support regulatory submissions or product launches
  • Leverages expertise across projects and specialties to effectively accomplish assignments and identify and mitigate risks within a project.
  • Leverages clinical and technical expertise to evaluate design and process risks and implement effective mitigation measures
  • Exhibits functional autonomy through creating project direction assigning design transfer deliverables required to support both new product development projects and design change projects
  • Reviews and edits internal documentation for team members and assists in the preparation and presentation of materials for internal or external technical reviews
  • May serve as a team lead and have direct reports
  • Supports Quality process improvement initiatives


Education

  • Bachelor's degree in relevant area


Experience

  • 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience


Certification

  • N/A


Skills

  • Strong attention to detail and documentation practices
  • Ability to work independently in a small-company environment
  • Effective communication and cross-functional collaboration
  • Problem-solving and investigative mindset
  • Strong knowledge of microbiological techniques and aseptic processing


Travel

  • N/A


Safety:

Physical Requirement

  • Move or lift objects up to 25 pounds
  • Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
  • Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)


Working Environment

  • Onsite: Office environment with assigned workstation
  • Remote positions only: Home office environment with minimum distractions


About RTI Surgical Inc

RTI Surgical Holdings, Inc. is a surgical implant company. The Company processes donated human musculoskeletal and other tissues, including bone, cartilage, tendon, ligament, fascia lata, pericardium, sclera and dermal tissues, and bovine and porcine animal tissues to produce allograft and xenograft implants utilizing BIOCLEANSE, TUTOPLAST and CANCELLE SP sterilization processes, and manufactures metal and synthetic implants for distribution to hospitals and surgeons. The Company's segments include Spine, Sports Medicine, Ortho fixation, Bone Graft Substitutes and General Orthopedic (BGS and General Orthopedic), Dental and Surgical Specialties. The Company's implants are used in orthopedic, spine, sports medicine, cardiovascular, dental and surgical procedures. The Company's processing facilities are located in Alachua, Florida; Neunkirchen, Germany; and Aix-en-Provence, France. The Company distributes its implants and services in the United States and internationally.
Learn more about RTI Surgical Inc
Size
891 employees
Market Cap
$185
Industry
Healthcare
Founded
1998
5 Year Trend
+320%
NASDAQ
RTIX
* Ladders Estimates

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