Systems Engineer

Digital Health Solutions; Andover (MA); In loco; USD 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) plan with employer match

Vision

Dental

Paid time off

Descrizione del lavoro

Digital Health Solutions in Massachusetts is seeking a Systems Engineer with experience in the medical device industry to translate customer needs into robust system requirements and support design activities.

The role collaborates with software, QA, and regulatory teams to ensure compliant, safe, and effective devices, contributing to risk analysis, design reviews, and verification activities in a quality-managed environment.

Competenze

• Bachelor's degree in engineering required; advanced degree preferred.
• 2+ years of experience in systems engineering for medical devices.
• Strong problem-solving and communication skills to convey complex concepts.

Mansioni

• Translate voice of customer into system requirements for medical devices.
• Develop system and subsystem requirements.
• Collaborate with hardware, software, QA, and regulatory teams to meet design controls and regulatory guidelines.
• Participate in safety and cybersecurity risk analysis activities.
• Support design reviews and verification/validation planning and execution.

Conoscenze

Systems engineering

Regulatory knowledge

Risk analysis

Formazione

Bachelor's degree in engineering

Advanced degree preferred

Descrizione del lavoro

Digital Health Solutions is a premier consulting company dedicated to providing comprehensive solutions to medical device companies. We specialize in helping our clients navigate the complexities of IEC 62304 and ISO 13485 compliance. Our team of skilled professionals is committed to delivering the highest level of service, ensuring that our clients' products are both safe and effective for their end users.

We are currently seeking a talented Systems Engineer to join our dynamic team. The ideal candidate will have experience in the medical device industry.

Responsibilities

• Translates voice of customer into user needs for medical device products.
• Develops system and subsystem requirements.
• Participates in hardware and software design and development activities, working with engineers to ensure the design will meet requirements.
• Participates in safety and cybersecurity risk analysis activities.
• Develops requirement verification protocols, ensuring the requirements may be verified in compliance with design controls and other QMS SOPs.
• Collaborate with cross-functional teams, including software development, quality assurance, and regulatory affairs, to ensure secure and compliant system development processes.
• Reviews and develops technical documentation to ensure the planned activities match the system and subsystem verification and validation approach.
• Reviews external testing reports including 60601, biocompatibility, FCC, usability, and cybersecurity
• Participates in Design Reviews and technical reviews
• Manages technical and schedule balance while coordinating with the project manager and functional leads to ensure the planned approach meets schedule constraints.
• Stay current with industry trends, emerging threats, and best practices in medical devices to continuously improve our services and maintain our competitive edge.
• Performs other tasks as required.

Qualifications

• Bachelor's degree in engineering discipline; advanced degree preferred.
• 2+ years of experience in systems engineering, with a focus on medical devices.
• Excellent problem-solving skills and the ability to work independently or as part of a team.
• Strong communication skills, both written and verbal, with the ability to effectively convey complex technical concepts to non-technical stakeholders.

Preferred Skills And Competencies

• Knowledge of IEC 62304, ISO 13485, ISO 14971, 21 CFR 820.30, ANSI/AAMI SW96, FDA Guidance for Cybersecurity in Medical Devices and other relevant medical device regulations and standards.
• Experience with risk assessments and developing risk mitigation strategies for complex systems.
• Experience working under a Quality Management System (QMS).

What We Offer

• Competitive salary and benefits package, including health insurance, 401(k) plan with employer match, vision, dental and paid time off.
• Opportunity to work with cutting-edge technology in the medical device industry.
• A supportive, collaborative work environment that fosters professional growth and development.
• The chance to make a meaningful impact on the safety and effectiveness of medical devices, ultimately improving patients' lives.