Work Location(s): Chadds Ford, PA (Greater Philadelphia Area)
Relocation Assistance: Ineligible
Visa Sponsorship: Ineligible
At MOBILion Systems, you’ll join a dynamic team committed to positively impacting healthcare by commercializing products that help people and save lives. Our products provide unprecedented sensitivity, resolution, and throughput that fuel the development of better therapeutics, the ability to detect disease earlier, and the power to attack diseases at their roots instead of their symptoms. Our technology reveals what others leave unseen!
This is an opportunity to join an outstanding and growing team with an inclusive culture that delivers meaningful insights to the entire company!
The Systems Engineer will be responsible for leading the development of commercial scientific instrumentation. The SE will be responsible for executing the technical development of next generation SLIM technology. They will drive the collection of requirements from Business & Product Strategy Teams and then work to ensure that these requirements are addressed at each stage of the product development process. The engineer will follow the product development lifecycle and have experience working within a Quality Management Systems’ policies, procedures, and protocols to ensure compliance with regulatory and industry standards and practices.
- Responsible for ALL technical aspects of the product: including the instrument, accessories, and software. Responsible for system concept and block diagram, through prototype development until design transfer to manufacturing.
- Requirements Engineering: development and review for completeness/correctness of product definition using JAMA requirements management software.
- Responsible for Verification and Validation. Leads the activity ensuring adequate requirements test coverage, protocol, and results review. This includes the creation of the verification protocol and its execution.
- Risk Management: FMEA, Product Safety, Defect Review Board(s) chair, Product change control
- Project task estimation and status reporting, accountable to the project manager.
- Lead systems level design reviews
- Strong understanding of instrumentation development in an ISO9001 environment.
- Adhere to MOBILion’s QMS policies, procedures, and protocols to ensure compliance with regulatory and industry standards and practices.
- Create plans, procedures, protocols, and reports to support product development lifecycle and stage gate review.
- Lead external safety and environmental regulatory certifications.
- Work with manufacturing and service personnel to improve quality, cost, manufacturability, and serviceability of products.
- At least 5 years’ experience with system or subsystem engineering including drafting requirements and verification activities.
- Experience leading design reviews
- Experience with complex products involving mechanical, electrical, and software systems.
- Strong written and oral communication skills.
- Strong understanding of product development in an ISO9001 environment.
- Detail oriented documentation skills
- Strong product design skills and troubleshooting ability.
- Excellent group interaction and negotiating skills
- Demonstrated track record of executing a product development plan from rudimentary lab prototype to commercial launch.
- Demonstrated organizational skills with the ability to handle multiple tasks with different priorities
- Ability to read and understand mechanical drawings and electrical schematics
- Bachelor’s degree in engineering, analytical chemistry, chemistry, or physics.
- Ability to work within the United States
- Willing to relocate to the Chadds Ford, PA region
Preferred Skills & Qualifications:
- Mass spectrometry instrument development experience
- An advanced degree in engineering, physics, or related discipline
- Strong project management skills
- Medical device regulatory and quality control experience
- Solid business and strategic acumen
- Successful work-related experience in leading cross-functional teams
- Proficient programming skills in one or more industry standard programming languages or firmware.
Our vibrant culture is built on shared values and our passion to positively impact healthcare. We foster amazing teams and have a bias toward action. We encourage everyone to bring their whole selves to work and grow together through development opportunities, mentorship, and shared successes. We’ve also got amazing benefits!
- Healthcare insurance for employees and their families
- Rich 401(k) offering with Company match
- Annual bonus potential
- Employee Stock Ownership program
- Generous paid time off benefits with paid year-end business closure
- Flexible work arrangements
- Onsite fitness center
- Free snacks and beverages
- Energetic & inclusive culture
MOBILion Systems is proudly committed to recruiting and retaining a diverse and inclusive workforce. As an Equal Opportunity Employer, we never discriminate based on race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical condition), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.