RTI Surgical Inc

Sr. R&D Engineer

RTI Surgical Inc • $100K — $120K *
Eden Prairie, MN 55347In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Material Science, Bioengineering, Chemistry, or related field; advanced degree preferred.
  • 4+ years of experience in the medical device industry.
  • At least 6 years of engineering experience with medical devices or implants.
  • Mastery of tissue engineering, biomaterials, and polymers.
  • Proven ability in design controls and risk management.

Responsibilities

  • Act as a Subject Matter Expert for product development projects and secure necessary regulatory approvals.
  • Collaborate with global cross-functional teams to advance product development initiatives.
  • Draft and author design control documentation according to internal SOPs.
  • Manage interactions with external vendors for testing and supply needs.
  • Independently author reports and presentations to communicate findings and progress.
  • Design and execute complex experiments, compiling and analyzing data for product innovations.
  • Ensure regulatory compliance with industry standards and protocols.

Benefits

  • Opportunity for mentoring and supervising less experienced engineers and interns.
  • Work in a high-impact role within a dedicated R&D team.
  • Engagement in innovative regenerative medicine projects.
  • Onsite office environment support with assigned workstation.
  • Involvement in global product development efforts.
Full Job Description
Location: On site: 6455 City West Pkwy Suite 100, Eden Prairie, MN 55344

Office hours: 8am-5pm

Salary Range: $100,000-$120,000 Annually

Bonus: eligible for $13,000 annual bonus

As Senior R&D Engineer, you will take full ownership of the technical execution for internal and contract product development projects. This is a high-impact role within the U.S. R&D organization, where you will be expected to champion innovation, navigate complex regulatory landscapes, and ensure the delivery of market-leading products through disciplined project leadership

RESPONSIBILITIES
  • Acting as a SME, champions complex product development projects: researching, developing, and securing regulatory approval for new regenerative medicine products.
  • Actively engage and collaborate on global cross functional product development teams.
  • Medical Device Design Control and Risk Management:
    • Leveraging a high level of experience and skill, independently draft/author all typical design control documentation in accordance with relevant internal SOPs such as: trace matrices, design verification plans and reports, risk documentation, design validation plans and reports, usability reports, final product labeling (including IFUs).
  • Identify and lead interactions with external vendors such as test labs (e.g. biocompatibility, animal study, and analytical) and suppliers.
  • Independently author engineering reports and presentations as required to document and communicate findings.
  • Applies deep knowledge and experiences from across multiple clinical segments to research, develop, and formulate new products/prototypes to develop innovative solutions to satisfy customer needs
  • Independently design, execute, compile data, and draw conclusions for complex experimentation.
  • Assist with clinical/user needs assessments.
  • Assist with intellectual property searches and evaluations.
  • Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as appropriate.
  • Supports process engineering efforts during process scale-up and manufacturing improvement initiatives.
  • Maintain a safe work environment and laboratory notebooks.
  • May mentor or supervise less experienced engineers, interns, and co-ops.
  • Other duties as reasonably assigned by the management team.

REQUIREMENTS:

Education

    • Minimum bachelor's degree in Material Science, Bioengineering, Chemistry, or related technical discipline. Advanced degree preferred.
    • 4+ years of medical device industry experience


Experience

  • At least 6 years' engineering experience designing or modifying medical devices or implants


Skills
    • Demonstrated mastery level knowledge with:
    • Tissue engineering, biomaterials, and polymers.
    • Design controls.
    • Risk management and creating risk analyses.
    • Laboratory prototyping.
    • Safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals, and materials.
    • Effective engineering problem solving tools.
    • QMS change control.
    • Thorough understanding of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments. Able to apply techniques and independently interpret results.
    • Experience in tissue engineering and biomaterials is a plus.
    • Ability to travel as needed (
    • Exceptional organizational, communication (verbal and written) and interpersonal skills.
    • Works independently with general direction and minimal supervision.
    • Attention to detail, effective problem solving and decision-making skills.
    • Knowledge of MS project software, Outlook, MS Excel, MS Word, MS PowerPoint.

Travel

  • 10%


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
  • Ability to lift and/or carry 50 lbs.


#LI-Onsite

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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