Senior Systems Engineer (R&D and Product Development) - Remote

MillenniumSoft Inc; San Diego (CA); Remote; USD 90,000 - 150,000; Full time

Job summary

Join a forward-thinking company as a Senior Systems Engineer, where your expertise in Systems Engineering will be vital in developing innovative medical devices. You'll play a key role in translating customer needs into actionable system requirements, leading cross-functional teams, and driving continuous improvement initiatives. This position offers the chance to work on diverse projects, ensuring product quality and compliance with industry standards. If you're passionate about making a difference in healthcare technology and thrive in a collaborative environment, this is the perfect opportunity for you.

Qualifications

• 5+ years of experience in Systems Engineering and medical device development.
• Bachelor's degree required; postgraduate degree preferred.

Responsibilities

• Translate customer needs into system requirements and specifications.
• Lead feasibility and risk assessments for system/product-level projects.

Skills

Systems Engineering

Medical Device Development

Requirements Management

Project Management

Communication Skills

Continuous Improvement

DFSS Knowledge

Reliability Engineering

Education

Bachelor's degree in Science or Engineering

Postgraduate degree

Tools

Team Foundation Server

Quality Management System in SAP

Job description

Position : Senior Systems Engineer – Remote (Work in PST time zone)

Location : San Diego, CA

Duration : 12 Months

Total Hours/week : 40.00

1^st Shift

Client : Medical Devices Company

Job Category : Engineering

Level of Experience : Senior Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Job Description:

• This Systems Engineer translates voice of customer and stakeholder needs into system and product requirements, identifies potential hazards, and assesses requirements to ensure that the product meets the user/business needs, develops design and process specifications for new hardware and software products, aids in product verification and validation, and provides support in sustaining activities.
• The expectation for a Senior Systems Engineer is that they regularly serve on smaller project core teams, act as a leader of technical excellence, and participate as an agent for continuous improvement within the Systems Engineering function.
• As such they are expected to help identify tasks/resources to ensure that critical project milestones are met, and systems integration activities are identified and fulfilled.
• A Senior Systems Engineer in this role is responsible for using their broad technical expertise, leadership skills, and product development knowledge to provide Systems Engineering support through various phases of product life cycle.

Essential Functions:

• Working knowledge of product development lifecycle, concept through launch.
• Leads system/product-level feasibility and risks assessments.
• Facilitates cross-functional knowledge and experiences to promote the understanding and resolution of in-market and product development issues.
• Responsible for coordination of system-level product development and its integration.
• Serves as a resource to examine system behavior issues and bring to resolution for on-market products.
• Identifies opportunities and drives continuous improvement efforts.
• Applies DFSS best practices on all projects.

Qualifications:

• Must have a Bachelor’s degree in Science or Engineering. A post graduate degree is preferred.
• At least 5 years related work experience required (combination of work experience and advanced degrees).

Skills/Attributes:

• Ability to work independently and as a member of a team.
• Ability to lead multi-discipline engineering teams.
• A strong technical background within Systems Engineering, medical device development, or similar.
• Experience with Systems Engineering and requirements management.
• Familiar with systems integration and testing, system architectural planning and design, Reliability Engineering, Project Management, and Failure Modes Effects Analysis.
• DFSS knowledge and experience or statistical test design and analysis knowledge or Critical Parameter Management.
• Excellent communication skills with the following departments: interdepartmental (with fellow engineers), cross-functional (with Marketing, Clinical Representatives, Software Engineers, Test Engineers, and Quality Engineers).
• Must have strong writing skills.
• Identified opportunities for continuous improvement projects/efforts.

Nice to have:

• Good understanding of Basic Safety and EMC Standards e.g. 60601-1, 61010-1, 60601-1-2.
• Good understanding of ISO 15223-1 and ISO 20417.
• Quality Management System in SAP.
• Team Foundation Server.