Are you looking for an exciting opportunity?
We currently have a full-time opening for a Product Engineer III (Carlsbad CA). If you are looking for a fast-paced environment where you can make a difference every day, then this is the opportunity for you!
The right person to join our team is...
Demonstrates ownership and accountability; the ability to plan, track, and accomplish goals; ability to communicate effectively both written and verbal. S/he will rely on extensive experience and judgement to make recommendations and/or decisions within the scope of their essential job responsibilities. Demonstrates the ability to lead, mentor and train others.
This position is responsible for....
As a Product Engineer III, in the medical device industry, you will play a critical role in driving the product development process from concept to production for complex medical device projects. You will collaborate with cross-functional teams to design, develop, and launch innovative products that meet customer needs, align with regulatory requirements, and support our company's strategic objectives. This position requires a results-driven individual with strong technical expertise, excellent problem-solving skills, and a passion for delivering high-quality medical devices.
Your day will be very busy... you will:
- Lead the development and execution of complex medical device product design and development plans, ensuring alignment with customer requirements, regulatory standards, and company objectives.
- Collaborate with multidisciplinary teams, including design, manufacturing, quality, regulatory affairs, and marketing to deliver innovative medical devices on time and within budget.
- Develop comprehensive product specifications, design documentation, risk assessments, and test plans for new medical devices.
- Perform advanced design validation and verification activities to ensure that medical devices meet performance, reliability, and regulatory requirements, including FDA and ISO standards.
- Identify and resolve complex technical issues during product development, testing, and production phases while considering patient safety and risk management.
- Conduct design reviews and provide expert feedback to improve product quality, performance, and compliance with industry-specific regulations.
- Drive continuous improvement initiatives by identifying opportunities to optimize processes, reduce costs, and enhance product performance.
- Mentor and guide junior engineers in their professional growth and development within the medical device industry.
- Stay current with industry trends, emerging technologies, and best practices in the medical device field to contribute to the innovation of new products.
What your background will be:
- Bachelor's degree in engineering (Biomedical, Mechanical, Electrical, or related field) from an accredited university is required. A master's degree is preferred.
- 7+ years of experience in product development within the medical device industry, with a proven track record of successful projects from concept to production.
- Strong understanding of engineering principles, materials, manufacturing processes, and quality control methods specific to medical device and sports medicine industries.
- In-depth knowledge of regulatory requirements and industry standards, including FDA regulations, ISO 13485, and other relevant guidelines.
- Proficient in CAD software (e.g., SolidWorks, AutoCAD) and other engineering tools specific to medical device and sports medicine product development.
- Computer proficient to include Microsoft Project, web browser/internet search, MS Outlook, MS Office to include Advanced Excel skills and the ability to produce presentation-ready slides in PowerPoint. Technical competence includes the ability to learn new software and systems.
- Experience with Oracle is preferred.
- Excellent problem-solving skills and the ability to apply engineering concepts to real-world situations within the medical device industry.
- Strong communication skills, both written and verbal, with the ability to lead and collaborate effectively with cross-functional teams and effectively communicate complex technical information to diverse audiences.
- Demonstrated ability to mentor and develop engineering talent within the organization.
What we can offer you...
Our insurance benefits are effective the 1st of the month after your hire date.
- Medical /Dental /Vision plans
- PTO (paid time off)
- Holiday Pay
- Life Insurance / STD / LTD
Pay Salary Range:
$105,000 - $120,000
For six consecutive years Breg has been awarded The National Business Research Institute (NBRI) Circle of Excellence Award for employee engagement.
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 workforce 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.
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