Engineer/Senior Engineer, Device Development Relocation Assistance Available

California, US residents click here (/ unither. com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202. 15. 24%20Combined%20EN%20and%20French. pdf#page=9) .

The job details are as follows:

What We Do

We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.

Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of 'medicines for life'. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.

How you'll contribute

The Senior Engineer, Device Development is responsible for leading research and development of medical device products and components used in combination products by applying technical and subject matter expertise. This role involves identifying and solving problems, leading product design and development projects, and supporting the R&D team in developing advanced organ therapeutics. This individual must be an innovative, adaptive, self-motivated, and experienced engineer eager to work cross functionally to define the proposed design, generate appropriate design control documentation, conduct verification and validation testing, and complete risk management activities.

• Develop the design control and risk management strategies for projects based on relevant regulations, industry standards, and the project scope

• Provide technical input and guidance in defining project priorities and timelines and crafting department goals

• Provide coaching, mentoring, and technical guidance to junior members of the team

• Develop preliminary device component designs that integrate seamlessly with biologic components of combination products

• Produce design prototypes and conduct feasibility performance evaluations to inform design selection and design freeze

• Develop and document design input requirements and user needs

• Define and create design output documentation including specifications and labeling

• Develop strategies for and participate in execution of verification and validation testing while maintaining appropriate testing and traceability documentation

• Author, review, and approve protocols, reports, and other supporting documentation for design verification and validation

• Lead risk management strategy development and conduct and document risk analysis activities such as PHA, dFMEA, and uFMEA as required by the risk management plan

• Communicate relevant information regarding project status, design details, and deliverable content to peer collaborators and executive stakeholders

• Collaborate with Quality, Regulatory, and other stakeholders on reviewing and approval completed documentation

• Serve as process owner for creating, organizing, and managing Design History Files

• Manage current relationships and develop new relationships with strategic business partners and external collaborators to represent the company and advance R&D projects

• Proactively identify technical needs of the Downstream R&D teams and ensure appropriate levels of support including work that may involve cells, tissues, and other biologic source materials

• Develop strategy for documenting and securing intellectual property

• All other duties as required

For this role you will need

Minimum Requirements forEngineer, Device Development

• Bachelor's Degree in materials science, chemical, biomedical, or mechanical engineering and 2+ years of relevant experience or a Master's degree with some relevant experience

• Technical expertise in ISO 13485 compliant Design Control and ISO 14971 compliant Risk Management activities

• Skilled at managing complex details, schedules, and timelines in support of design and development projects

• Knowledge of good documentation and good manufacturing practices

• Ability to use mathematics to solve problems

• Ability to organize, analyze, and present complex data

• Excellent written and oral communication skills

Minimum Requirements forSenior Engineer, Device Development

• Bachelor's Degree in materials science, chemical, biomedical, or mechanical engineering and 5+ years of relevant experience (or 3+ years of relevant post-masters experience or 1+ year of relevant post-doctorate experience)

• 3+ years of experience performing ISO 13485 compliant design control activities

• 3+ years of experience performing ISO 14971 compliant risk management activities

• Experience in prototype design and construction

• Ability to use mathematics to solve problems

• Ability to organize, analyze, and present complex data

• Work effectively with a cross-functional team to make project decisions

• Ability to work independently and as part of a team

• Excellent written and oral communication skills

Preferred Qualifications forEngineer, Device Development

• Master's Degree in materials science, chemical, biomedical, or mechanical engineering

• Experience in rapid prototyping and/or component fabrication and manufacturing processes

• Experience with combination products that include device and biologic components

• Knowledge of kidney and liver anatomy, biology, and physiology

• Proficient in statistical analysis

• Ability to work independently and as part of a team

Preferred Qualifications forSenior Engineer, Device Development

• Master's Degree in materials science, chemical, biomedical, or mechanical engineering or Doctor of Philosophy (PhD) in materials.