Experience Inc. Jobs

Systems Engineer

Newark, DE, United States

Join Our Team as a Systems Engineer – Sustaining and Drive Innovation in Medical Technologies!

Are you a passionate and talented systems engineer ready to make a significant impact on healthcare? We are seeking a dynamic Systems Engineer – Sustaining to join our cutting-edge team. In this thrilling role, you will maintain and enhance technical platforms and system specifications for Hologic’s on-market products. You'll tackle design challenges head-on, propose innovative solutions, and deliver high-quality design changes to our world-class medical imaging systems and devices.

If you're ready to take on an exciting and rewarding role that drives innovation in medical technologies, apply today and become a vital part of our mission to improve clinical outcomes and elevate healthcare standards!

What You'll Do:

• Technical Mastery :

• Dive deep into understanding system architecture design and clinical use of our on-market products.

• Be the go-to expert for system-level information requests from regulatory, marketing, and quality departments.

• Seamlessly complete R&D portions of project intake assessments and change control forms, ensuring every project is executed flawlessly.

• Innovative Solutions :

• Define and propose system specifications that meet new customer requirements and user needs.

• Play a key role in concept, specification, and design development of changes to existing products, fueling innovation and excellence.

• Comprehensive Traceability :

• Maintain meticulous traceability between system requirements and subsystem requirements.

• Ensure all product requirements, identified risks, and mitigation pathways are thoroughly documented and traceable.

• Hands-On Troubleshooting :

• Get hands-on with system and sub-system troubleshooting, ensuring every issue is resolved efficiently.

• Collaborate with design engineers and system quality assurance teams during concept, implementation, and verification phases.

• Collaborative Testing :

• Partner with design engineers to establish methods and conditions for testing.

• Complete design documentation and Engineering Change Orders, adhering to Hologic’s high standards and best practices.

• Project Leadership :

• Lead design change projects that drive meaningful improvements in product quality and manufacturing efficiency.

• Create and manage project schedules, monitor progress, and provide timely updates to management and core teams.

• Seamless Design Transfer :

• Facilitate the smooth transfer of designs to manufacturing, ensuring high-quality outcomes.

• Build and maintain collaborative relationships with all stakeholders within the division.

• Professional Growth :

• Manage multiple projects concurrently under the guidance of a senior engineer.

• Continuously seek out opportunities for professional development, channeling your interests and development needs to grow within the company.

Qualifications:

• Education and Experience :

• 3+ Years Experience in Medical Device or Regulated Environments

• Technical Bachelor’s Degree, Engineering required.

• Skills :

• Proficiency in systems engineering methodologies and modeling tools.

• Expertise in hardware and software integration in complex systems.

• Knowledge of medical devices, FDA QSR, ISO 13485, and risk and electrical safety standards (ISO 14971, IEC-60601-1, IEC 60601-1-2).

• Understanding of software life cycle for medical devices (IEC 62304) and Product Life Cycle Management systems.

• Strong critical thinking, problem-solving, and analytical skills.

• Excellent written and verbal communication, technical documentation, and project management skills.

• Interpersonal skills, including leadership, teamwork, coordination, and presentation development and delivery.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $76,800 - $120,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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