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Director, Device Development - Fort Wayne, United States - Norwest Venture Partners
Description
Company Address:11711 N. Meridian Street, Suite 300, Carmel, IN 46032, US
Salary Range:
$50,000 - $150,000
About MBX Biosciences MBX Biosciences, Inc. is a clinical stage biopharmaceutical company pioneering investigational Precision Endocrine Peptides (PEPs). PEPs are designed to overcome key limitations of native peptide therapeutics to deliver superior pharmacologic properties. MBX is advancing a pipeline of PEP candidates to address the unmet needs of people with endocrine disorders.
About MBX Biosciences MBX Biosciences, Inc. is a clinical stage biopharmaceutical company pioneering investigational Precision Endocrine Peptides (PEPs). PEPs are designed to overcome key limitations of native peptide therapeutics to deliver superior pharmacologic properties. MBX is advancing a pipeline of PEP candidates to address the unmet needs of people with endocrine disorders.
Job Description
The Director/Senior Director of Device Development will lead the device development team and report to the Vice President of CMC.
The successful candidate, in close consultation with marketing, medical, program management, regulatory, quality and other MBX technical functions, will lead and implement device development programs to bring forward combination products that meet unmet user needs and intended uses while fulfilling regulatory requirements.
Key ResponsibilitiesLead the MBX device development team.
Deliver the company's device development programs on schedule and within budget by collaborating with and influencing internal/external stakeholders.
Apply engineering first principles to think critically, guide the design, and drive the execution of device development programs.
Proactively manage third party design and development partners across a broad range of technologies and device types.
Oversee the development and maintenance of design history file documentation for medical device development.
Oversee risk management activities for combination product development including hazards analysis, design FMEA, process FMEA, and URRA.
Manage external usability/human factors engineering activities.
Support design transfer and the establishment of commercial device assembly, labeling, and packaging capabilities at third party CMO's.
Support the implementation of the device Quality Management System in close partnership with the quality organization.
Apply technical and regulatory expertise to support global regulatory submissions.
Effectively manage multiple projects and responsibilities concurrently
Education
Bachelor's degree in engineering (Mechanical, Biomedical, or similar); advanced degree beneficial
Experience
10 years-plus of relevant experience in combination product or medical device development and leading technical teams
Demonstrated record of designing and developing a broad range of combination products/medical devices from technical landscape evaluation to feasibility evaluation through verification, validation, design transfer, and launch with a focus on syringe and cartridge-based subcutaneous injection devices.
Working knowledge of systems engineering, design control, risk management, verification & validation, and human factors.Detailed knowledge of combination product and drug development processes and practices including design controls per 21CFR 820.30, ISO 13485,change control, deviation management, risk management/ISO14971.
Detailed knowledge of medical device regulatory directives and (e.g. FDA, EMA and ICH) with a demonstrated ability to articulate and apply these requirements to development plans.Working knowledge of pharmaceutical industry regulatory directives, guidance, and compendia for packaging components and container closure systems (e.g. FDA, Ph.
Eur., USP, WHO)
Experience directly contributing to regulatory submissions and agency interactions.
Additional Skills and Qualifications
Strong background in device development strategy, execution, and technical leadership with the ability to anticipate and resolve issues with little guidance from senior leadership.
Excellent written and verbal communication skills, and the ability to clearly articulate development and implementation challenges/strategies to a broad range of stakeholders having varying understanding of combination product development.
Ability to influence stakeholders and drive effective and timely decision-making.Effective project management and cross functional team collaboration skills.
Effective coaching, mentoring, and supervision of engineers and technical staff
Expected travel is ~ 20-25%, domestic and international
Company Overview:
MBX Biosciences is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide (PEP) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives.
Our team is driven to transform the current treatment landscape with highly efficacious, safe, and convenient medicines that are designed to address unmet needs in both rare and prevalent endocrine diseases.
We are combining our deep expertise in peptide discovery and development with our novel, proprietary platform technology to advance our pipeline.
Our lead programs have clinically validated targets and attractive endocrine disease market opportunities.MBX 2109 is an investigational long-acting parathyroid hormone peptide prodrug in development as a PTH replacement therapy for the treatment of hypoparathyroidism.
The company is building a pipeline of additional product candidates to treat endocrine disorders that will enter Phase 1 development in 2023.
MBX is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, OrbiMed, Wellington Management, RA Capital and Norwest Venture Partners.
We are based in the Indianapolis area and growing rapidly in a hybrid workplace environment.When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, passionate about their work, and able to work in a dynamic environment.
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.
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