Engineering Jobs in Research Triangle Park

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer

About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.

Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

Supervisory Responsibilities: 

·      None 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 Salary Range:

$190,000-210,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

Senior Director, Process Engineering & Contract Manufacturing Scale-Up

Location: Durham, NC (In-Office) 

Reports To: SVP Operations

Applying

To apply directly to this role, please email a non-ChatGPT paragraph explaining why you believe you would be the best fit for this role and attach your resume as a PDF. Applying via email is the only way to be considered.

About Carpe

Carpe is the fastest-growing deodorant brand in the United States. Our team is composed of ~25 incredibly smart people working together in person in downtown Durham, NC. Our office is open, collaborative, and high energy.

We build products that solve real problems for millions of people who struggle with excessive sweating. Our growth over the past several years has been rapid, and we are continuing to expand across retail, ecommerce, and new product categories.

As the company scales, building a strong, reliable, and scalable manufacturing foundation is critical to our long-term success.

The Role

We are seeking a high-ownership process engineering leader with a strong chemical engineering background who thrives in fast-growing environments and enjoys building systems that support scale. This is not a procurement or vendor management role. It is a technical manufacturing role focused on process engineering, scale-up, and improving manufacturing performance.

This role exists to build Carpe’s manufacturing process engineering capability as we expand production across multiple product categories and manufacturing partners. The primary focus is on developing robust, scalable processes that consistently deliver product performance.

This is a hands-on technical role. You will work directly with manufacturing teams to define critical process parameters, troubleshoot production challenges, and improve process reliability as we scale.

You will partner closely with Product Development, Operations, and Quality to translate product innovation into well-defined, scalable manufacturing processes. Success in this role requires the ability to develop long-term process engineering frameworks while also working directly with manufacturing teams to solve technical challenges and improve production performance.

What You’ll Do

Process Engineering & Manufacturing Science

• Build and lead Carpe’s internal manufacturing process engineering capability
• Work directly with contract manufacturing teams to document and refine production processes
• Identify and define critical process parameters that drive product consistency and performance
• Lead process characterization work, including DOE design and execution
• Improve process robustness and repeatability across manufacturing partners
• Troubleshoot complex manufacturing challenges and support manufacturing teams in solving production issues
• Drive continuous improvement initiatives across manufacturing operations

Technology Transfer & Product Scale-Up

• Lead the technical transfer of new products from development into commercial manufacturing
• Work directly with contract manufacturers to scale formulations and processes successfully
• Partner closely with Product Development to translate product specifications into scalable manufacturing processes
• Oversee pilot trials, validation runs, and commercialization readiness for new product launches
• Ensure new products are successfully and reliably launched across manufacturing partners

Manufacturing Performance & Continuous Improvement

• Establish operational metrics and performance tracking across contract manufacturing partners
• Improve manufacturing efficiency, yield, and process reliability
• Lead root cause investigations and corrective actions related to manufacturing issues
• Implement stronger process control and operational discipline across manufacturing partners
• Develop scalable manufacturing frameworks that support continued company growth

Cross-Functional Collaboration

• Partner closely with Product Development to ensure manufacturing processes support product performance requirements
• Collaborate with Quality and Regulatory to ensure manufacturing processes meet compliance and quality standards
• Work with supply chain and planning teams to support production scheduling and inventory needs
• Provide manufacturing insight during product development and innovation planning

Contract Manufacturing Leadership

• Own and manage Carpe’s network of contract manufacturing partners
• Build strong working relationships with technical teams at manufacturing partners
• Improve operational performance across quality, delivery, and cost
• Lead onboarding and qualification of new manufacturing partners as capacity expands
• Ensure manufacturing partners are prepared to support both current production and future growth
• Serve as the primary operational leader responsible for manufacturing performance across the network

Who You Are

• Bachelor’s degree in Chemical Engineering, Manufacturing Engineering, or a related technical discipline
• 10–15+ years of experience in manufacturing, process engineering, or operations leadership within consumer packaged goods, personal care, or related industries
• Experience with emulsions, OTC personal care, or topical formulation manufacturing
• Experience managing contract manufacturing networks and external production partners
• Strong technical background in manufacturing processes and scale-up
• Experience working with highly structured emulsions or shear-sensitive formulations
• Demonstrated ability to build systems, processes, and infrastructure in growing organizations
• Comfortable operating in fast-moving environments where both strategy and hands-on execution are required
• Willing and able to travel a lot (and last minute) 
• Strong engineering instincts and problem-solving ability
• Ability to work directly with manufacturing partners to improve processes and solve technical challenges

Bonus If You Have

• Background in manufacturing engineering or process engineering leadership roles
• Experience scaling products across multiple contract manufacturing sites
• Experience building manufacturing infrastructure in high-growth CPG environments

What You’ll Get

• Direct collaboration with senior leadership as we scale the business
• Opportunity to build and own Carpe’s manufacturing infrastructure during a major growth phase
• Competitive compensation based on experience and level
• Health, vision, and dental coverage
• Flexible PTO
• A front-row seat to the growth of one of the most disruptive brands in body care



Applying

To apply directly to this role, please email a non-ChatGPT paragraph explaining why you believe you would be the best fit for this role and attach your resume as a PDF. Applying via email is the only way to be considered.

Akkodis is seeking Health & Safety Specialist in Durham NC 27703

Job Title: Health & Safety Specialist

Location: Durham NC 27703

Pay Range:$36/hr - 43.50/hr (The pay range may be negotiable based on experience, education, geographic location, and other factors)

Duration : 12 Months Contract

Job Description:

• Assist in the development and implementation of the site’s EHS programs and procedures to ensure compliance with local, state, federal requirements.
• Provide EHS-related training to colleagues and contractors, including new-hire EHS orientation and refresher training.
• Design and lead the EHS FOCUS program (including annual refresher training [Talk]; monthly Walk activities; supervisor inspections [Detect]; process confirmation [Check]; and award recognition [Together]). Analyze data to continuously improve the program. Provide routine reports to management.
• Develop and implement programs to improve the site’s EHS culture and compliance -- including behavior based safety; ergonomic awareness, evaluations and solutions; pre-shift workplace stretching; and good catch/near-miss/concern reporting.
• Manage the Durham site’s VPP Program application to successfully meet NC OSHA requirements for Carolina Star including hosting inspections, audits, document preparation, etc.
• Provide EHS expertise and support to dispersed workforce (e.g., technicians, sales force, veterinary staff, etc.) of Cattle, Poultry and Swine USA operations. Host monthly safety meetings with colleagues. Complete periodic ride-along visits to observe colleague’s field operations and ensure implementation of EHS programs. Provide recommendations for safety improvements aimed at reducing risks, improving safety culture, ensuring compliance, and reducing injuries. Manage injury logs, workers compensation filings and internal reporting requirements,
• Conduct routine site audits, safety walks, environmental inspections and other related evaluations (as needed) to identify systemic EHS management gaps. Develop and track corrective measures and implement solutions to sustain compliance.
• Manage and report EHS-related information (injury/illness, environmental metrics, risk assessments, EHS action items) into the Company’s EHS online system (Cority). Submit all EHS reports as required by regulatory authorities.
• Participate on injury/illness investigations and identify root cause and corrective/preventive actions. Provide coaching on practical EHS behaviors, work practices and solutions.
• Develops EHS notices, postings, newsletter and other communications, as requested.
• Participate on the site’s Emergency Response Team and Safety Committee.
• This role will report to the site’s EHS & Facility Manager and will interact with Operations, Manufacturing, R&D, Facilities, Engineering, Quality, Distribution and office operations including working with all levels of the organization and be visible in the operational areas to support a safe and compliant work environment.
• Bachelor’s degree in environment, safety, occupational health, ergonomics, engineering or a similar technical discipline.
• Minimum of five (5) year of EHS-related experience. (Open to new graduate with related internship or job shadow experience).
• Professional certification (CSP, CIH) preferred.
• Thorough knowledge and interpretation of federal and North Carolina safety and environmental regulations and programs including Carolina VPP Star.
• Strong interpersonal and diplomacy skills, leadership, analysis, judgment, creativity, practical problem solving, flexibility, as well as excellent written and oral communication skills.
• Solid computer capabilities including Microsoft Word, Excel, PowerPoint and SharePoint.
• Ability to facilitate meetings, perform multiple tasks simultaneously, work independently, easily make decisions, and handle emergency situations.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance

Puneet Rajput

Resource Development Manager

T

E

Akkodis is a commercial brand under which both AKKA & Modis entities operate.

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• Pursuing opportunities at institutions such as Naval Postgraduate School (NPS) or Navy War College (NWC)
• Completing Joint Professional Military Education (JPME) at one of the various service colleges

EHS Consultant — Global Engineering Construction Projects

Position Overview

Intuitive Safety Solutions (ISS) is seeking an experienced Environmental, Health & Safety (EHS) Consultant to support a large-scale construction project within a global engineering environment. This role provides governance, oversight, and strategic safety leadership throughout project planning, mobilization, and execution phases.

The EHS Consultant will function as a trusted advisor to project leadership, working closely with Construction Management (CM), General Contractors (GC), and operations stakeholders to ensure effective implementation of safety programs and alignment with Global Engineering Safety & Health Assurance expectations.

This position blends administrative leadership with field engagement, focusing on proactive risk management, safety culture development, and performance monitoring across multi-employer construction environments.

Reporting Structure

• Functional reporting to the Project Manager.
• Secondary reporting to the Americas Lead for Global Engineering Construction Safety.
• Close collaboration with Operations Safety teams and project stakeholders.

Work Environment

• Approximately 75% office/administrative responsibilities.
• Approximately 25% field-based engagement supporting project safety oversight.

Project Phases & Responsibilities

Early Stage Planning (March–April | ~8–16 hours/week)

• Provide project orientations and safety indoctrination sessions for project teams and construction management personnel.
• Support CM/GC teams with lower-tier contractor outreach and onboarding alignment.
• Assist in reviewing early safety and health project plan submittals for compliance with regulatory and organizational requirements.
• Contribute to early risk planning and safety program alignment.

Execution & Mobilization (May–June onward | Full-Time | 40 hours/week)

• Lead periodic project safety meetings and contribute to weekly project tier meetings.
• Participate in Global Engineering safety peer forums and knowledge-sharing initiatives.
• Review pre-planning safety documentation including JHAs, AHAs, and RAMs for regulatory compliance and adherence to Global Engineering Safety & Health Assurance Program standards.
• Conduct periodic team walks to evaluate field safety performance and compliance.
• Perform documented audits, inspections, and performance assessments.
• Monitor CM efforts to establish and maintain a strong safety culture, including workforce understanding and perception.
• Track leading indicators, analyze trends, and provide insight to project leadership.
• Provide governance and oversight for root cause investigations and corrective actions following incidents.
• Support alignment between construction execution teams and global safety expectations.

Required Qualifications

• Minimum 10+ years of environmental, health, and safety experience with strong emphasis on construction safety.
• Experience supporting multi-employer construction environments.
• Demonstrated leadership presence and ability to influence across multiple organizations.
• Strong knowledge of OSHA Construction regulations and regulatory compliance frameworks.
• Excellent communication skills with ability to engage both executive stakeholders and field teams.
• Strong analytical and reporting capabilities.

Preferred Qualifications

• 2–3+ years in a leadership or oversight role on complex construction projects.
• Experience in highly regulated or mission-critical environments such as:
• Pharmaceuticals
• Biotechnology
• Data center construction
• Oil & gas
• Chemical or industrial facilities
• Associate or Bachelor’s degree in Occupational Safety & Health or related field.
• Nationally recognized certification such as:
• BCSP CSP
• BCSP CSM
• BCSP CHST
• BCSP CSHM
• BCSP ASP
• NASP MSP
• NASP CSD

Key Traits for Success

• Strong governance mindset balanced with practical field awareness.
• Ability to influence without direct authority.
• Analytical thinker focused on leading indicators and proactive risk reduction.
• Collaborative leader who builds alignment across diverse teams.
• Detail-oriented with strong documentation and reporting skills.

Responsibilities:

• Collaborate with Accounting and Finance team to effectively manage the budgeting & forecasting process.
• Closely monitor & communicate to the Vice President; Project Status/Risks & Opportunities.
• Participate in management committee meetings within all assigned joint ventures.
• Manage the pursuit of project claims & change orders.
• Responsible for ensuring the development & use of a CPM schedule throughout the life of the project.
• Engage project and corporate level contract management to address & resolve contractual issues & claims.
• Participate in project level staff meetings and all major decisions.
• Establish & promote a safety culture through active representation.
• Oversee procurement or Buy-out process to ensure it adhere to set budget.
• Sponsor additional revenue strategy including REA's and claims.
• Establish and maintain relationships with key business partners.
• Effectively oversee subcontract management.
• Coach and develop staff.
• Carry out job duties while maintaining Lane values

Qualifications:

• Bachelor's Degree in Civil Engineering, Construction Management or related field.
• Minimum 15 years heavy civil construction experience.
• Excellent written and verbal communication skills.
• Ability to assess, evaluate, and solve problems.
• Knowledge of regulatory laws and responsibilities.
• Organizational skills; attention to detail.
• Teamwork and leadership skills.

Job Opportunity: Senior Automation Engineer – Cary, NC

About Precis

Precis Engineering + Architecture (Precis) is a 150+ person consulting firm with offices in Ambler, Pa., and Cary, N.C., offering comprehensive design services. Precis has been repeatedly recognized as a Best Place to Work by the Philadelphia Business Journal.

Position Overview:

The Senior Automation Engineer supports the Cary, N.C., office with expertise in Rockwell or Allen Bradley systems. This role is responsible for the development, programming, and testing of PLC systems integrated with HMI and SCADA. This individual will also play a key role in on-site installations and commissioning, requiring local travel to install, maintain, and troubleshoot equipment. Experience with PlantPAx would be beneficial; experience with Siemens or DeltaV is a huge plus.

Key Responsibilities:

• Develop instrument lists (IO list), loop sheets, motor elementaries, and VFD diagrams for various control systems.
• Collaborate with clients to design and develop PLC systems that include HMI and SCADA, ensuring all customer requirements are met.
• Program, test, and troubleshoot PLC systems to guarantee optimal performance during installation and commissioning phases.
• Conduct training sessions for operators and maintenance staff to ensure they are proficient in operating and maintaining the systems.
• Develop and maintain detailed documentation for the software development life cycle (SDLC), including PLC, HMI, and SCADA programs, user manuals, and maintenance procedures.
• Work closely with clients to ensure their satisfaction by meeting specific system requirements and ensuring the functionality of the systems.
• Provide ongoing technical support to clients during and after the installation and commissioning process.

Qualifications

• Bachelor's degree in electrical or chemical engineering or equivalent.
• Professional license (e.g., PE) not required; working toward PE/EIT a plus.
• Proven track record with 5–10 years of expertise in the Rockwell PLC systems. Candidates must demonstrate mastery in developing complex PLC, HMI, and SCADA solutions from the ground up.
• Expertise in Siemens (TIA Portal/S7) is highly desirable and will be considered a significant advantage.
• Proficiency in programming languages like Ladder Logic and Function Block Diagrams.
• Ability to develop programs based on customer-provided documents, such as FRS and SDS.
• Expert knowledge of Rockwell Automation Software Suite, including Rockwell Studio 5000, FactoryTalk View ME, and FactoryTalk View SE.
• Knowledge and implementation experience with industrial communication protocols – Ethernet/IP, Modbus TCP/IP, BACnet/IP, Profibus.
• Excellent communication and interpersonal skills, with the ability to work both independently and as part of a team.
• Willingness to travel to customer sites for installation and commissioning (local travel in N.C., approximately 25%).

Why Join Precis?

• Be part of a collaborative, innovative team that values your ideas and expertise.
• Shape growth for a respected, specialized engineering and architecture firm.
• Enjoy a flexible, supportive work environment and competitive compensation package.

Equal Opportunity Employer

Precis provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics.

Senior Systems Engineer

Gilero is a leading medical device design, development, and manufacturing partner. We specialize in creating innovative solutions that improve patient care and enhance lives. Our growing dynamic team of professionals works across disciplines to bring ideas to life, from concept to commercialization.

We are seeking a highly skilled Senior/Staff Systems Engineer to lead and contribute to the development of complex medical devices and combination products. The ideal candidate will bring a systems-level perspective, integrating mechanical, electrical, and software components while ensuring compliance with regulatory and quality standards. You will be responsible for leading systems engineering project activities for medical device and drug delivery applications. This role is pivotal in bridging engineering disciplines to deliver safe, effective, and innovative healthcare solutions.

Join us in a collaborative and innovative environment where your contributions will make a real difference. You'll work with multiple clients across a variety of cutting-edge products to help shape the future of healthcare technology, ensuring products meet the highest standards and positively impact patient outcomes across the globe.

Responsibilities:

• Acts as technical lead throughout the full product development lifecycle from initial concept to release to market of new medical devices; primarily class I and class II electro-mechanical devices.
• Provides expertise in various Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, change management, and reliability.
• Plans systems engineering projects by identifying appropriate system development lifecycles.
• Develops product development strategies for large or complex systems integrations.
• Generates system architecture definitions, integrations, development viewpoints, and models.
• Manages the system architecture and relates it to the design throughout the lifecycle.
• Defines requirements hierarchy and how it relates to verification and validation planning.
• Performs functional system decompositions to solve complex design challenges.
• Prepares detailed component and assembly drawings. Leads and participates in writing product and customer requirements, design and phase reviews, product and process risk assessments, root cause investigations, and corrective action planning.
• Plans, authors, and executes test methods and protocols for design verification and validation.
• Analyzes test data, interprets results, and formulates conclusions.
• Maintains the Design History File (DHF) and ensures documents are complete, accurate, current, and compliant with regulations.
• Contributes to developing systems engineering tools and processes and trains others to use those systems.
• Identifies technical opportunities and generates work for themselves within their assigned project teams.
• Defines objectives, participates in, and oversees the quality of output for large or complex projects.
• Contributes to solving open-ended problems and tasks with a high level of decision-making.
• Formulates and develops detailed project deliverables with some management oversight.
• Communicates technical risks and proposed solutions clearly and directly with the customer.
• Sources and interfaces with third-party vendors.
• Acts as subject matter expert (SME) lead in one or more areas and is aware of industry trends.
• Supports business development efforts as a SME to potential customers and providing input on engineering estimations.
• Establishes a proven track record of building trust and rapport with new clients.
• Acts as mentor demonstrating strong leadership skills.
• Participates in recruitment activities including interview panels.
• Travel will be required, as necessary (typically less than 5%).

Skills/Qualifications:

• BS in Engineering or equivalent technical degree.
• Work onsite in the Durham, NC office four days per week.
• 5+ years relevant experience.
• Experience developing electro-mechanical medical devices.
• Proven ability to lead a product development program from concept to market release.
• Working knowledge of system modeling tools and methodologies (e.g., UML, SysML).
• Working knowledge of working in both agile and waterfall methodologies.
• Proficiency with SolidWorks or other 3D CAD (Computer Aided Design) modeling software.
• Working knowledge of requirements management software (e.g., Jama, Polarion, Doors).
• Working knowledge of developing products for compliance with IEC 60601 for electrical safety and for software development.
• Working knowledge of developing products for compliance with FDA 21 CFR Part 820.30, 21.
• CFR Part 4, ISO14971, ISO 13485 and EU MD.

Personal Attributes:

• Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity.
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements.

Eligibility To Work:

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why work at Gilero:

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.