Product Development Engineer - Medical Device Job at Katalyst HealthCares and Life Sciences, Broadview Heights, OH

QkY2LzA3ZnJtSVQ4OFBib2Y0NEhLcnE1WFE9PQ==
  • Katalyst HealthCares and Life Sciences
  • Broadview Heights, OH

Job Description

Summary :

  • Proficiency in CAD (Solid Works Creo), GDT, tolerance analysis, and fixture design.
  • Knowledge of orthopedic testing standards (ASTM F382, F543, F1717, F2077, ISO 1424214243, etc.).
  • Strong capability in test protocol report writing, statistical analysis (9595, tolerance intervals), and data integrity practices.
  • Familiarity with materials and processes Ti alloys, CoCr, stainless steel, UHMWPE, PEEK, AM, coatings. Understanding of design controls, ISO 13485, ISO 14971, and regulatory pathways (510(k), PMA, MDR).
  • Experience with external lab management, including protocol alignment, fixture approval, deviation handling, and report review.
  • Competence in risk management tools (DFMEA, pFMEA) and traceability from requirements to verification.
  • Skilled in project management and cross-functional communication, using tools like MS Project, Minitab.


Roles & Responsibilities :

  • Lead product development for orthopedic implants and instruments from concept through design transfer.
  • Author and execute test protocols and reports per ASTMISO standards, ensuring risk-based acceptance criteria and regulatory compliance.
  • Act as primary liaison with testing labs prepare technical data packages, approve fixtures, clarify protocol details, and ensure proper sample handling and chain-of-custody.
  • Support lab test execution by coordinating logistics, reviewing set-up photos videos, witnessing critical tests, and resolving deviations promptly.
  • Maintain design controls and risk management per ISO 14971 and 21 CFR 820 throughout the project lifecycle.
  • Plan and perform design verification and validation (DVV) including benchtop, simulated use, and preclinical testing.
  • Collaborate with manufacturing and suppliers for DFMA, process validations, and design transfer readiness.

Education & Experience :

  • Skilled in project management and cross-functional communication, using tools like MS Project, Minitab.
  • 4-6 years of experience in Supplier Quality or Product Quality Engineering in medical device industry

Job Tags

Full time,

Similar Jobs

DLM Pro

Class A CDL Driver - Home Daily - No Touch Freight Job at DLM Pro

 ...Class A CDL Driver Home Daily No Touch Freight Pay: $1,350 per week Schedule: Nights & Weekends...  ...Drivers for a homedaily position running local and shortregional freight. This role...  ...Equipment: Modern, wellmaintained trucks Requirements ~ Valid Class A... 

WakeMed Health & Hospitals

Mental Health Technician I - Mental Health Job at WakeMed Health & Hospitals

Overview:The Mental Health Tech I provides direct patient care and management of patients with medical and behavioral issues under the supervision of a Clinical Nurse by performing patient care services, crisis intervention, therapeutic interactions and milieu management... 

State of Washington

District Wildlife Biologist - Fish & Wildlife Biologist 4 - Permanent - 2025-09053 Job at State of Washington

 ...Permanent Job Number: 2025-09053 Department: Dept. of Fish and Wildlife Opening Date: 12/18/2025 Closing Date: 1/4/2026 11:59...  ...team and help shape recommendations for wildlife management conservation and recreation, and contribute to tribal co-management harvest... 

Granite Telecommunications

Corporate Trainer Job at Granite Telecommunications

 ...Job Summary We are seeking a dynamic and motivated Corporate Trainer with 1-2 years of experience in training facilitation and instructional design. This individual will play a key role in delivering engaging training programs to enhance teammate performance and drive... 

Everglades Equipment Group

Grade A/B Mechanic Job at Everglades Equipment Group

Technician is responsible for repair and maintenance of a variety of agricultural, lawn maintenance and construction equipment. This technician may be required to go out into the field and service equipment. Candidate will be required to demonstrate a variety of skills ...