Address
Form of work
Position Title:
Product Engineer III
This position is responsible for….
The Produce Engineer III leads the development and execution of complex medical device product design and development plans, ensuring alignment with customer requirements, regulatory standards, and company objectives. Collaborates with multidisciplinary teams, including design, manufacturing, quality, regulatory affairs, and marketing to deliver innovative medical devices on time and within budget. Develops comprehensive product specifications, design documentation, risk assessments, and test plans for new medical devices. Performs advanced design validation and verification on activities to ensure that medical devices meet performance, reliability, and regulatory requirements, including FDA and ISO standards. Identifies and resolve complex technical issues during product development, testing, and production phases while considering patient safety and risk management. Conducts design reviews and provide expert feedback to improve product quality, performance, and compliance with industry-specific regulations. Drives continuous improvement initiatives by identifying opportunities to optimize processes reduce costs and enhance product performance. Mentors and guide junior engineers in their professional growth and development within the medical device industry. Stays current with industry trends, emerging technologies, and best practices in the medical device field to contribute to the innovation of new products.
Requirements:
This position may be required to lift up to 50 pounds.
Ability to travel domestic and internationally (Mexico) 10% of the time. Telecommuting permitted 1-2 days per week but must be available to come into the office in Southlake, TX when needed.
Bachelor's degree (or foreign equivalent) in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field + 3 years of experience as a Product Engineer III, Manufacturing Engineer, or similar role. The 3 years of experience as a Product Engineer III, Manufacturing Engineer, or similar role must include 3 years of experience with the following:
Experience in product development within the medical device industry.
Experience with engineering principles, materials, manufacturing processes, and quality control methods specific to medical device and sports medicine industries.
Experience with regulatory requirements and industry standards, including FDA regulations, ISO 13485, and other relevant guidelines.
Experience using CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools specific to medical device and sports medicine product development.
Experience using Microsoft Project, web browser/internet search, MS Outlook, MS Office to include Advanced Excel skills and the ability to product presentation-ready slides in
Experience using PowerPoint.
Experience using Oracle.
Experience applying engineering concepts to real-world situations with the medical device industry.
Experience leading and collaborating with cross-functional teams and communicating complex technical information to diverse audiences.
Experience mentoring and developing engineering talent within an organization.
Hours:
40 Hours/WK. (8am-5pm)
Location of Employment:
2380 Dean Way, Ste. 140, Southlake, TX 76092
How to Apply:
If you meet the requirements above and would like to apply for this position, please visit our website at www.breg.com and click on the ‘Careers’ section.
Breg is an Equal Employment Opportunity Employer and dedicated to a diverse work force and Drug Free work environment. EOE/Minorities/Females/Vet/Disabled are encouraged to apply.
Applicants must be currently authorized to work in the United States on a full-time basis. The Company will not sponsor applicants for work visas for this position.
