4 дня назад
Project Engineer (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Project Engineer (Medical Devices): Developing and optimizing allograft processing and manufacturing processes for clinical applications in spine and orthopedic surgery with an accent on tissue characterization, analytical testing, and quality compliance. Focus on designing validation protocols, transferring R&D processes to production, and preparing technical and regulatory documentation under FDA, AATB, and GMP requirements.
Location: San Antonio, TX, United States
Company
develops medical technologies, while its Bone Bank Allografts subsidiary processes and distributes bone allografts for orthopedic, dental, and reconstructive procedures.
What you will do
- Conduct allograft processing activities and tissue characterization for clinical applications.
- Design and execute experimental protocols, analyze data, and prepare technical reports.
- Perform, troubleshoot, and optimize manufacturing and analytical processes.
- Train and support manufacturing personnel during R&D process technology transfer to production.
- Support process qualifications, validations, and post-launch improvements.
- Author and review SOPs, protocols, regulatory submissions, patents, and scientific publications.
Requirements
- B.S. or M.S. in Biology, Biomedical Engineering, Biomedical Sciences, or a related field.
- Experience in allograft process development, manufacturing, analytical testing, or quality systems; hands-on experience is preferred.
- Proficiency in designing and executing qualification and validation protocols.
- Comprehensive knowledge of GMP, FDA, and AATB regulatory requirements.
- Strong communication, problem-solving, organization, documentation, data-tracking, and regulatory-compliance skills.
- Ability to meet physical requirements, including lifting up to 25 pounds regularly and up to 65 pounds occasionally.
Nice to have
- Prior tissue banking experience.
- Wet lab experience.
- Previous industry experience.
Culture & Benefits
- Innovation focused on improving patient care and advancing medical technology.
- Customer-focused, collaborative, respectful, and accountable working environment.
- Results-oriented culture emphasizing energy, decisiveness, and overcoming obstacles.
- Commitment to ethical business practices, regulatory compliance, inclusion, and equal employment opportunity.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
1 день назад
Manufacturing Engineer (Medical Devices)
5 часов назад
Director of Global Facilities Engineering & Center of Excellence (Medical Devices)
187 400 - 281 000$
6 дней назад
Process Engineer (2 years+) (Medical Manufacturing)
4 дня назад
Engineer (Biotechnology)
14 часов назад
Principal Engineer, R&D (Medical Devices)
112 000 - 154 000$
3 дня назад
Senior Supplier Quality Engineer (Medical Devices)
99 200 - 148 800$