- Apply sound engineering principles and practices to the design, development, and testing of biomaterials-based, drug delivery implants, and their delivery systems
- Develop, set-up, and utilize bench and preclinical models to evaluate performance of innovative bioabsorbable therapies
- Manage product development activities with external vendors
- Document development activities in technical reports and lab notebooks
- Write work instructions, test methods, batch records, study protocols and other technical documents related to product development and manufacturing
- Lead design control deliverables as products progress through development
- Lead/assist in risk management activities and deliverables
- Lead/assist in the preparation of regulatory submissions, scientific/engineering papers, grant applications, invention disclosures, and patents
- Lead/assist in the upgrade of current delivery system and in the design of next generation delivery systems
- Execute timelines and milestones as part of project planning
- Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the design and manufacture of human use products
- Manage suppliers on the design and procurement of tooling and fixtures that aid in product development, testing, and/or inspection
- B.S. degree in an Engineering or Scientific field with 5 or more years' of industry experience in the development of medical devices or combination products
- Highly knowledgeable in Design Control with experience taking products through Design Verification and Validation
- Areas of expertise: product, process and test method development as well as mechanical design, prototyping, biomaterials
- Knowledge and experience in biomedical test method development, validation, and execution
- Experience and working knowledge of the U.S. and International standards governing the design, development and manufacture of drug products and medical devices
- Ability to work on multiple projects simultaneously, prioritize assignments, and adapt in a fast-paced environment
- Excellent written and verbal communication skills
- Experience using SolidWorks
- Collaborative team player who enjoys working in a highly dynamic, cross-disciplinary environment
- Must be able to analyze and interpret data, apply sound statistical techniques, and communicate issues, findings, processes and ideas in a clear, concise, technically-proficient manner
-
Development Engineer
1 week ago
BlueNova Industries Highland City, United StatesAbout the Company · We are a globally leading specialist in adhesives for the core segments of industry, construction, and consumers. For over a century, we have been developing innovative solutions that make adhesives smarter and more adaptive to make our daily lives easier. Wit ...
-
Software Development Engineer/Technician
1 week ago
Sapphire Enterprises Wayland, United StatesAIP develops and manufactures specialized testing equipment for the automotive industry with approximately 250 employees. Our equipment is primarily used in research and development, type testing, and quality assurance. We design and produce custom vehicle or component test bench ...
-
Development Engineer
1 week ago
Crimson Enterprises Westwood, United StatesYour Role · Development of software functions in the automotive industry · Analysis and coordination of requirements · Testing of software functions on computer and in vehicles · Integration of functions into a complete system · Commissioning of functions on test benches and in v ...
-
Development Engineer Electronics
1 week ago
ZephyrTech Woburn, United StatesThe electronic concept GmbH has been developing since 1995 from a two-man operation to a medium-sized EMS manufacturing specialist with a highly motivated team of over 50 qualified employees. We offer our customers a wide range of services in the field of electronics. · Our custo ...
-
Development Engineer
1 week ago
NovaWorks Solutions Lowell, United StatesYour tasks · Development of innovative fastening products · Responsibility for the entire product development cycle from concept phase to market launch · 3D modeling, design, and drawing creation of products using Autodesk Inventor · Creation of technical specifications for produ ...
-
Development Engineer
1 week ago
Eclipse Enterprises Lowell, United StatesAre you... · responsible for power electronics for space applications (satellites, subsystems, and payloads) · in charge of satellite power supply (power supply and distribution, battery management, solar panels and their drives/control, power supply and conditioning for all ele ...
-
Infinity Systems Highland City, United StatesCreate Fascinating Things: Your Responsibilities · Implementation of development tasks in the field of new development and product support · Design and development of new hydraulic systems and further development of existing hydraulic system solutions · Specification/definition o ...
-
Development Engineer Electrical Engineering
1 week ago
Eclipse Innovations North Scituate, United StatesOur client is a renowned partner in the electronics and electrical industry and a reliable, appreciative employer with national and international customers, as well as modern production facilities in the country and contract manufacturing abroad. We are looking for a full-time De ...
-
Development Engineer Hardware
1 week ago
Velocity Enterprises New Canton, United StatesYour tasks: varied and responsible · You develop complex hardware platforms while considering internal and external requirements. · You also work on the development of complex microcontroller circuits, taking into account EMC and environmental requirements in circuit and PCB desi ...
-
Downstream Development Engineer
2 weeks ago
Dragonfly Therapeutics Waltham, United States Full timeDownstream Development Engineer · Dragonfly Therapeutics seeks an Associate Engineer, Downstream who brings enthusiasm, intellectual curiosity, scientific rigor and a desire to help drive novel biologics programs. The candidate must be independent, goal-oriented, flexible, and ab ...
-
Senior Software Development Engineer
3 days ago
Hitachi Data Systems Waltham, United StatesWe're Hitachi Vantara, a global infrastructure business. Our people are the force of meaningful progress. We enable the incredible with data – from taking theme park fans on magical rides, conserving natural resources, protecting rainforests to savinglives. We empower businesses ...
-
Software Development Engineer Test
3 days ago
SS&C Technologies Waltham, United StatesSS&C is a global provider of investment and financial services and software for the financial services and healthcare industries. Named to Fortune 1000 list as top U.S. company based on revenue, SS&C is headquartered in Windsor, Connecticut and has 20,000+ employees in over 90 of ...
-
Senior Product Development Engineer
3 days ago
Lyra Therapeutics Waltham, United StatesLyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-21 ...
-
Software Development Engineer Test
3 days ago
SS&C Technologies Waltham, United StatesSS&C is a global provider of investment and financial services and software for the financial services and healthcare industries. Named to Fortune 1000 list as top U.S. company based on revenue, SS&C is headquartered in Windsor, Connecticut and has 20,000+ employees in over 90 of ...
-
Process Development Engineer I
3 days ago
Alkermes Waltham, United StatesJob Description · This position designs and executes experimental studies to develop well understood, robust oral solid dosage manufacturing processes. Key duties are process design, equipment set-up, troubleshooting equipment, running experiments, collecting, and evaluating dat ...
-
Senior Concept Development Engineer
6 days ago
Boston Scientific Waltham, United StatesAbout the role: · Boston Scientific is a global medical technology leader for more than 35 years. Our mission at Boston Scientific is to transform lives through innovative medical solutions that improve the quality of patient care. The Waltham-based division is a small, dynamic, ...
-
Stellar Enterprises Somerville, United StatesTake the next step in your career as a Software Engineer in Supply Chain Management with Somerville. · Budenheim includes various plants, including those in Spain and Mexico. With our approximately employees, we have been producing specialty products and phosphates in the field o ...
-
R&d Software Director
1 week ago
Boston Scientific Corporation Waltham, United States**Work mode**:Onsite**Onsite Location(s)**:Waltham, MA, US, 02138**Additional Location(s)**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** · - At Boston Scientific, we'll give you the opportunity to harness all that's within you ...
-
Project Director
2 days ago
Simpson Gumpertz & Heger Waltham, United States**Do you want to help engineer what's next?** · Simpson Gumpertz & Heger (SGH) is a national engineering firm committed to delivering holistic advice for our clients' most complex challenges. We leverage our collective and diverse experience, technical expertise, and industry kno ...
-
Technical Account Manager
1 day ago
Ansys Waltham, United States**Requisition #**: 13527 · **Our Mission: Powering Innovation That Drives Human Advancement**: · When visionary companies need to know how their world-changing ideas will perform, they close the gap between design and reality with Ansys simulation. For more than 50 years, Ansys s ...
Senior Product Development Engineer - Waltham, United States - Lyra Therapeutics
Description
Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically nave patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.
We are looking for a hands-on Product Development Engineer to work on the design and development of a novel transmucosal therapeutic system. The successful candidate must have previous experience developing medical device or combination products, thrive in a fast-paced start-up environment, be adaptable to work on several aspects of product development, and be motivated by the opportunity to learn new technologies.
Responsibilities