Product Development Engineer

Product Development Engineer Origin Biologics Las Vegas, NV Job Details Full-time From $65,000 a year 1 hour ago Benefits Health savings account Health insurance Dental insurance 401(k) Paid time off Employee assistance program Vision insurance 401(k) matching Life insurance Qualifications Quality control within healthcare industry Engineering Production validation processes Bachelor's degree Biomedical regulatory compliance Manufacturing company experience Full Job Description Company Summary Our primary mission is to provide the highest quality orthopedic implants to restore, repair, and regenerate biological and mechanical functionality lost due to degenerative diseases or trauma-related incidents. Origin Biologics, Inc. (OB) is part of the EBOS Group, a publicly listed global healthcare organization. Position Summary he Product Development Engineer is responsible for all aspects of the design, execution and interpretation of process and product development and validation studies for HCT/P's and medical devices. This includes supporting new product development initiatives, validation, technology transfers, process improvements, and optimization projects. The role is required to interact with management, other members of the staff, suppliers, third-party laboratories, customers, and manufacturers. International travel to Australia to liaise with Research and Engineering team will be periodically required. Industry experience in medical device, biologics, tissue banking, or a related regulated life sciences field is required. Candidates must have experience in the medical device, biologics, tissue banking, or a related regulated life sciences industry. Reasonable Accommodations Statement To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Functional Responsibilities:

Support project plans and timelines within new product development guidelines. Provide technical engineering support for projects and other functions of the company. Support project planning includes budgeting, design inputs and outputs, design verification and validation, and design transfer to production. Identify and define performance requirements for allograft, medical device, and instrumentation systems. Support process risk activities (FMEA) to support new and existing products and processes. Develop verification and validation protocols and complete design verification studies. Establish acceptance criteria, perform data analysis, and generate final reports. Write, review and revise QMS documentation, including policies, procedures, and forms. Support concept designs and coordinate prototype manufacture. Identify, coordinate, and support engineering change requests. Ensure products adhere to company and industry quality standards and regulations. Support process qualification and verification activities in cleanroom environments. Support training activities for production personnel. Perform investigations and root cause analysis for non-conformances and implement CAPAs. Any other ad hoc duties and projects critical to engineering and the organization.

Education :

Bachelor of Science in Engineering or related scientific discipline.

Experience :

Minimum 2+ years of experience in product development, process development, validation, or commercialization activities. Minimum 3+ years' experience in the medical device, biologics, tissue banking, pharmaceutical, or related regulated industry). Experience working within regulated quality systems and product development lifecycle activities is required.

Certifications/Licenses :

Certifications in a technical discipline relevant to the position (e.g. Certified Quality Engineer, Certified Process Validation Engineer, CTBS Certification). Certifications are not required but are considered a plus for candidates with specialized validation or quality systems experience.

Other :

Understand the requirements of

FDA 21 CFR, ISO

13485, and AATB standards. Understand the requirements of GLP, GMP, USP, and ISO guidelines and methodologies Fundamental knowledge of aseptic techniques and principals Experience with equipment/method/process validation design and acceptance criteria Experience with handling biohazardous material (human, biological and chemical samples) Knowledge of basic sterilization practices using steam sterilization, gamma or electron beam radiation Strong technical writing skills and statistical data analysis capabilities

Pay:

From $65,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person