This position reports directly to the Bio Services Manager. The Bio Services Senior Engineer will support the newly rebranded Bio Services Group. The core areas in the rebranded group will focus around invitro-diagnostics, point-of- care, assay integrations, microfluidic prototyping, and instrument development. This position defines and maintains the vision for the Business Development Program Design function at StarFish specifically in developing opportunities in this new space. Key practice areas in the Bio Services group include: microfluidics, microbiology and regenerative medicine.
This position will offer you:
- The satisfaction of helping others through medical device technology
- An organization with strong core values
- A team oriented/collaborative environment
- An award winning company culture & tight knit team
- Profit sharing
- Competitive compensation
- Excellent benefits package
- Monthly All-hands meetings
- Active social committee
- 50% TTC/Transit subsidy in Toronto
- Bike Share station within 5 minute walk and shower facilities for midday runs or biking to work in Toronto
You will be a technically minded project leader interfacing directly with clients and overseeing technical Bio Services project success You will support several advanced research & development programs and be the primary interface between the “science” and the engineering. You will have familiarity with a broad range biotechnology disciplines including invitro-diagnostics and regenerative medicine and advanced therapies. Current areas of focus require an advanced knowledge of molecular diagnostics and tissue engineering. The primary products are medical devices developed under ISO 13485. Ideal candidates will possess an advanced biomedical degree, and be an expert in one or more of the core practice areas (Point-of-care diagnostics, microbiology and regenerative medicine). In addition, you will have product development experience preferably in a variety of roles including project management and system engineering. The candidate requires good knowledge of biochemistry, physiology, basic microbiology/cell culture laboratory skills, along with a good understanding of Design for Manufacturing and Assembly.
- You will be a technically minded project lead interfacing directly with clients and overseeing technical Bio Services project success
- Work collaboratively in cross-functional teams comprised of individuals from various disciplines;
- Analyze and summarize data
- Troubleshoot Assay problems
- Write development and validation reports and SOPs
- Support project teams through assistance in BSL2 laboratory work
- Material research; familiar with a variety of materials including plastics, biochemistries, biological interactions
- Biomedical research; familiar with general microbiology, biochemistry, physiology
- Identify capable suppliers and vendors to purchase and expedite the delivery of key biological components or reagents
- Work with manufacturing personnel to develop assembly procedures for mechanical/electrical/biochemical assemblies related to biological considerations
- Assist with laboratory related report writing, protocol generation and SOP development
- Practice clear documentation techniques
- Assist with training and supervision of projects students
- Any other related duties, as required
- Bachelor, Masters or PhD in Engineering, Applied Science or Science.
- A minimum of 5 years technical experience in one or more of the core practice areas (microfluidics, microbiology and regenerative medicine).
- Experience with Product Development in a Quality Management System environment would be considered an asset.
- Demonstrated knowledge and understanding of product development processes, preferably in biologics, regulatory pathways for medical devices and biologics (e.g. FDA, EMA), and knowledge of GLP and GMP an asset.
- Demonstrated ability to work effectively as part of a team and in a multi-site/multicultural organization where effective multi-tasking and both intra and cross-program communication is essential for efficient mission accomplishment.
- Strong verbal and written communication skills.
How to Apply:
After reviewing the Job Description at www.TallSky.ca to learn about the finer details of the Bio Services Senior Engineer role, qualified applicants are encouraged to apply in confidence to TallSky Consulting with a resume and cover letter that clearly indicates how your education and experience meet the requirements of this position.
We thank all applicants who apply; however after initial acknowledgement, only those selected for further consideration will be contacted.