Lead Engineer
1 week ago
A leading life sciences company, BioSpace, Inc. is committed to delivering innovative medicines and solutions that address serious health issues.
We strive to have a remarkable impact on people's lives across various therapeutic areas, including immunology, oncology, neuroscience, and eye care, as well as products and services in our Allergan Aesthetics portfolio.
About the Role
BioSpace, Inc. is seeking a Senior Technical Director to lead the Engineering Testing & Analysis group (ETAG) within Combination Product Development & Drug Delivery. This is a key role with a direct impact on our exciting and rapidly growing portfolio of combination products, focusing on continuous infusion and subcutaneous injection systems.
Key Responsibilities:
- Direct project activities and professional development of a team of testing engineers by effectively mentoring, guiding, and supervising personnel.
- Serve as a technical lead on projects while contributing engineering insights into multiple other projects.
- Critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
- Mentor/supervise a team of engineers and/or scientists and evaluate their performance.
- Supervise the design and execution of experiments supporting feasibility, development, and verification stages of product development to meet project timelines and all relevant regulatory compliance requirements.
- Analyze, document, and present results to cross-functional teams.
Requirements:
- A degree in an engineering field (mechanical, materials, packaging, bioengineering): BS or equivalent education and extensive experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience
- Strong expertise in Design Verification for Medical Devices and experience working in a regulated environment in compliance to 21 CFR 820 and MDR.
- Significant background in engineering testing and analysis, including direct experience of test equipment validation (IQ, OQ, PQ), statistical analysis, and documentation experience.
- Demonstrated effective leadership skills, deliverables produced on time, and personnel development plans in effect.
- Recognized and sought out as an expert in their discipline.
- Project management competencies in budgeting and resource planning as well as scheduling and tracking of project tasks.
Compensation Information:
This is an on-site opportunity located in BioSpace, Inc.'s North-Chicago offices. The estimated salary range for this position is $120,000 - $180,000 per year.
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