Engineering Journal Jobs in Research Triangle Park

Job Description:

We believe in bold ideas, diverse perspectives, and the drive to transform knowledge into impact. Here, your curiosity fuels progress, your voice shapes innovation, and your ambition helps redefine what's possible within science and learning. We are a culture that obsesses over impact, challenges, and drives what's next to power infinite possibilities for our customers, colleagues and society at large.

About the Role:

We power infinite possibilities.

For more than 200 years, we've transformed knowledge into discoveries that shape the world. Today, our global team of innovators, creators, and experts is driving what's next in science, education, and publishing-creating impact that reaches everywhere.

We're not just observers of progress. We're the ones accelerating scientific breakthroughs, advancing learning, and sparking innovation that redefines entire fields and improves lives.

Here, your talent matters. Your ideas have room to grow. And your work creates breakthroughs that can change everything.

Wiley is an equal opportunity/affirmative action employer. We evaluate all qualified applicants and treat all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, protected veteran status, genetic information, or based on any individual's status in any group or class protected by applicable federal, state or local laws. Wiley is also committed to providing reasonable accommodation to applicants and employees with disabilities. Applicants who require accommodation to participate in the job application process may contact for assistance.

We are proud that our workplace promotes continual learning and internal mobility. Our values support courageous teammates, needle movers, and learning champions all while striving to support the health and well-being of all employees. We offer meeting-free Friday afternoons allowing more time for heads down work and professional development, and through a robust body of employee programing we facilitate a wide range of opportunities to foster community, learn, and grow.

We are committed to fair, transparent pay, and we strive to provide competitive compensation in addition to a comprehensive benefits package. The range below represents Wiley's good faith and reasonable estimate of the base pay for this role at the time of posting roles either in the United Kingdom, Canada or USA. It is anticipated that most qualified candidates will fall within the range, however the ultimate salary offered for this role may be higher or lower and will be set based on a variety of non-discriminatory factors, including but not limited to, geographic location, skills, and competencies.

When applying, please attach your resume/CV to be considered.

Salary Range:

Job Posting Title:

Location:

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.

• 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

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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Akkodis, part of The Adecco Group North America located at 4800 Deerwood Campus Parkway, Building 800, Jacksonville, FL 32246, is committed to data privacy compliance. To learn more about how we collect and process personal information, please read our General Privacy Policy located on the website above

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.

A Clinical Case Educator requires the credentials of a Registered Nurse. In this role, a registered nurse is passionate and is committed to provide a high level of patient care and counseling patients enrolled in the Medication Therapy Program. The ideal candidate has great communication skills, problem solving skills, and must be self-motivated. This person will be driven to help team members to achieve the mission of providing high level of care to patients. This position is a telehealth position. The nurse will report adverse events and provide clinical interventions to the patient based on assessed need.

Must reside within a commutable distance of Cary, NC or Fort Worth, TX.

Shift Information

• Cary, NC – Monday-Friday from 9am-6pm EST and one night per week rotating to work 11-8pm.

• Fort Worth, TX - Monday-Friday from 8am-5pm CST and one night per week rotating to work 10-9pm.

• The nurses are required to report to the office twice a week.

• One rotating Saturday.

Key Responsibilities

• Counsel and educate new/existing patients on specialty drug therapies.

• Adherence to contracted and accrediting regulations as indicated by drug specification.

• Complete, thorough, and accurate documentation utilizing good documentation practice and compliance to industry standards and regulations.

• Discuss potential/current side effects with patients to educate about treatment alternatives and facilitate ongoing therapy adherence.

• Identify and report adverse events (AEs) and product complaints (PCs) to the manufacturer, FDA, and/or other governing authorities.

• Specialty drug verification and education. Provider/patient conduit to support therapeutic longevity.

• Adherence to patient management programs through call cadence schedules, medication management programing, drug counseling and provider collaboration.

• Maintenance of patient demographic records, medical history, and records in accordance with federal HIPAA standards.

• Collaboration with Pharmacy Support teams to ensure timely and accurate delivery of specialty drugs.

Minimum Requirement

• Degree or equivalent and typically requires 4+ of relevant experience or a combination of education and experience.

• Active RN license in NC/TX.

Education

Associates, Bachelor or higher degree in Nursing or accredited nursing diploma.

Critical Skills

• 4+ years of nursing experience with at least 1 year of acute.

• Experience in Oncology or other specialties.

• Registered Nurse with current unrestricted compact state license or primary NC licensure. TX RN license is required for residents of TX.

• Ability to obtain licensing in all states and United States territories serviced within 3 months of employment through Biologics supported programming (minimal application guidelines apply.)

• Computer skills, including e-mail, word processing, spreadsheet and web-based programs.

• Effective orally and in writing communication, experience with motivational interviewing preferably.

• Ability to read, analyze and interpret practice standards, professional journals, technical procedures and government standards and regulations.

• PTO Blackout Dates – around Thanksgiving, Christmas, and New Years holidays.

Physical Requirements

• Large percent of time performing computer-based work is required.

• Hybrid position-Office days required.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position

McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson’s (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:

McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.

McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.

McKesson job postings are posted on our career site: .

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

McKesson welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. If you require accommodation please contact us by sending an email to .

Join us at McKesson!

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. 

Why Deliver with DoorDash?

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• Total flexibility:Dash when it works for you. Set your own hours and work as much—or as little—as you want. 
• Know how much you'll make:Clear and concise pay model lets you know the minimum amount you will make before accepting any offer.
• Instant cash flow:Get paid the same day you dash with DoorDash Crimson*. No deposit fees, no waiting.
• Quick and easy start:Sign up in minutes and get on the road fast.**
• Simple Process:Just pick up, drop off, and cash out. Payday is in your back pocket.

Basic Requirements

• 18+ years old*** (21+ to deliver alcohol)
• Any car, scooter, or bicycle (in select cities)
• Driver's license number
• Social security number (only in the US)
• Consistent access to a smartphone

How to Sign Up

• Click “Sign UpApply Now” and complete the sign up process
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**Subject to eligibility..

***Must be 19+ in Arizona, California, Colorado, Delaware, Florida, Georgia, Idaho, Kentucky, Montana, New Jersey, New Mexico, Texas, Utah, and West Virginia

Additional information

Dashing with DoorDash is a great earnings opportunity for anyone looking for part-time, seasonal, flexible, weekend, after-school, temporary, steady delivery gig. Deliver with DoorDash and earn extra cash while being your own boss. Dash when it works for you. Sign up today.

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.