Jobs at Soteira

• Conduct ongoing market research, competitive analysis, and customer needs assessments to identify market opportunities and support product positioning.
• Gather Voice of Customer (VOC) feedback from surgeons, healthcare professionals, and key opinion leaders (KOLs) to define product requirements and guide development activities.

• Lead the sterile barrier packaging design and development for Musculo-skeletal implants.
• Provide guidance on process validation activities (for both new packaging configurations and packaging production lines).

• Product Development:

Lead the design and development of surgical instruments and implants using CAD software (CREO).
Create and maintain project plans and FDA-compliant Design History Files (DHF) for each project.
Manages all aspects of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies
Perform design verification and validation activities to ensure designs meet specifications.
Partner with in-house prototype shops and external vendors for rapid prototyping and evaluation.
Assist in writing regulatory applications to the FDA and other regulatory bodies.

• Creates and manages project plan(s) for each project in conjunction with the Project Engineer
• Leads coordination and documentation of project team activities including kick-off meetings, design review meetings, verification/validation activities, cadaver labs for multiple projects within group

• Is able to work on sizeable individual efforts as well as on teams using agile methodologies.
• Develops prototypes, proofs of concept in addition to production-quality solutions.

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate ab our role in improving the lives of patients by continuously developing better solutions.
• Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.

• Champion Clean Architecture, SOLID principles, and test-driven development, ensuring our apps meet the highest standards of quality, reliability, and regulatory compliance. In addition to mobile development, you will also maintain and enhance our existing Windows-based programmer application, ensuring stability and compliance with regulatory standards. If you are passionate about building elegant solutions that make a real difference in patients’ lives, this is your opportunity.

• Design and implement embedded and PC-based software that interfaces with implantable stimulators and external accessories.
• Define software requirements, create detailed designs, implement and test code, and perform verification and validation in accordance with internal and external standards.

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
• Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.

• Lead cross-functional teams to develop and execute strategic product plans and objectives
• Conduct complex market and competitive analyses to identify unmet needs, whitespace opportunities, and differentiation strategies

• Develops and maintains software applications & systems development
• Creates and maintains product software architecture