Job Description
Position Summary
The Device Engineer, will be responsible for managing device development activities in support of MBX’s combination product pipeline. This role will focus on the execution and coordination of design, development, and commercialization activities for drug delivery systems, working cross-functionally with internal teams and external partners. The successful candidate will contribute technical leadership and project management expertise to ensure the timely delivery of high-quality, compliant device solutions that meet patient and regulatory needs.
Key Responsibilities
- Manage and execute device development activities for pipeline programs under guidance from senior leadership.
- Collaborate with cross-functional teams including Marketing, Regulatory, Quality, Medical, and Program Management to align device development with overall program goals.
- Support the design and development of delivery devices such as syringe and cartridge-based injection systems.
- Contribute to and maintain design history file (DHF) documentation and support design control activities in accordance with 21 CFR 820.30 and ISO 13485.
- Coordinate with external design/development and manufacturing partners, including contract engineering firms and CMOs.
- Assist in risk management efforts, including hazard analysis, design FMEA, and process FMEA.
- Support usability and human factors engineering activities with external experts.
- Participate in design transfer and commercial readiness activities related to device assembly, packaging, and labeling.
- Collaborate closely with Quality to support implementation and maintenance of the device Quality Management System (QMS).
- Provide technical input for global regulatory submissions and responses to health authority questions.
- Manage and prioritize multiple device development projects simultaneously.
- Other responsibilities as assigned.
Education & Qualifications
- Bachelor’s degree in Mechanical, Biomedical, or related Engineering discipline; advanced degree preferred.
- 8+ years of experience in medical device or combination product development, with experience managing projects or technical teams.
- Demonstrated experience in device design, verification and validation, and design transfer activities.
- Familiarity with syringe, autoinjector, and cartridge-based subcutaneous delivery systems.
- Working knowledge of design control, risk management (ISO 14971), human factors, and combination product regulations.
- Experience collaborating with regulatory, manufacturing, and quality teams.
- Experience working with third-party vendors and contract manufacturers.
- Strong project management and organizational skills.
- Excellent written and verbal communication, including conveying technical information to non-technical audiences.
- Strong problem-solving skills and a proactive mindset.
- Ability to work effectively in a fast-paced, cross-functional environment.
- Team-oriented with the ability to lead small technical teams or workstreams
Company Overview:
MBX Biosciences, Inc. (NASDAQ: MBX) is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders. The Company was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow us on LinkedIn.
EEO Statement:
MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.
